After an often-painful, 14-year journey to use tiny needles to deliver drugs, an East Bay company could win regulatory approval by the end of the year to cut through the pangs of severe migraines. Zosano Pharma Corp. (NASDAQ: ZSAN) said Wednesday that the Food and Drug Administration accepted its new drug application for Qtrypta, setting off a 10-month review process that will lead to an approval decision by Oct. 20 for its microneedle patch carrying the generic migraine drug zolmitriptan. It is the 55-employee Fremont company's deepest trip into the FDA drug-approval process — and what a strange trip it's been.

It is not uncommon to see companies perform well in the years after insiders buy shares. On the other hand, we'd be...

Here's a roundup of top developments in the biotech space over the last 24 hours. Scaling The Peaks (Biotech stocks that hit 52-week highs Nov. 13.) Antares Pharma Inc (NASDAQ: ATRS ) Arrowhead Pharmaceuticals ...

Zosano Pharma Corporation (ZSAN), a clinical-stage biopharmaceutical company, today announced that it is commencing an underwritten public offering of units consisting of shares of common stock and warrants to purchase common stock. H.C. Wainwright & Co. is acting as the sole book-running manager for the proposed offering. A registration statement relating to these securities has been filed with the U.S. Securities and Exchange Commission (SEC) and became effective on March 27, 2019.

FREMONT, Calif., May 14, 2020 -- Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, today announced financial results for the first quarter.

FREMONT, Calif., Nov. 14, 2019 -- Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, today announced financial results for the third quarter.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering. A registration statement relating to these securities has been filed with the U.S. Securities and Exchange Commission (SEC) and became effective on March 27, 2019. The offering is being made only by means of a written prospectus and prospectus supplement that will form a part of the registration statement.

Here's a roundup of top developments in the biotech space over the last 24 hours. Scaling The Peaks (Biotech Stocks Hitting 52-week highs on Feb. 11) AbbVie Inc (NYSE: ABBV ) Acceleron Pharma Inc (NASDAQ: ...

It has been three weeks since the coronavirus-driven volatility hit the global economy, and the market continues to rapidly move into both the green and the red. Since its February 19 peak, the S&P 500 has ultimately shed 15% of its value, with it swinging violently in either direction on a seemingly daily basis. As for the other major U.S. indexes, they seem to be following this pattern to a T.Given the uncertainty related to how long the aftermath of the virus’ outbreak will weigh on the market, investors are turning to the pros for guidance, namely healthcare investing guru Hal Mintz. The New York investment banker, who previously managed BAM Capital, has earned a Street reputation as being a trusted source of stock picking inspiration. Currently leading the Sabby Capital hedge fund, which primarily focuses on small-cap healthcare names, Mintz has grown the equity portfolio to reach $361 million, according to the latest 13F filling. As a result, when Mintz makes a move, Wall Street watches.Bearing this in mind, we took a closer look at three small-cap biotech stocks Sabby Capital added to the portfolio recently. After running the tickers through TipRanks’ Stock Screener tool, we found out that analysts see plenty of upside in store for each of these Buy-rated names. Let’s dive in.Zosano Pharma (ZSAN)Using its patented intracutaneous microneedle patch technology, Zosano Pharma wants to provide a safe, simple and fast acting method for drug delivery. While shares have taken a nasty tumble since the start of the year, some believe that a turnaround is on the horizon.Hal Mintz falls into this category. On February 12, Sabby Capital snapped up 3,576,491 shares at $0.65 cents apiece. The total purchase value comes in at more than $2.3 million, with the fund now a 9.99% owner of the company.Based on its Adhesive Dermally Applied Microarray (ADAM) technology, Maxim analyst Anthony Vendetti remains confident in the company’s long-term growth prospects. Specifically pointing to its Qtrypta therapy for migraines and cluster headaches, the analyst noted that there is a significant market opportunity. Among current patients suffering from migraines, 74% receive insufficient treatment, according to a MAST (Migraine in America Symptoms and Treatment) study from 2017. “In our opinion, Qtrypa has the ability to provide a fast, non-oral treatment for migraines, which according to the Migraine Research Foundation, is the third most prevalent disorder in the world,” he stated.The drug’s NDA was accepted by the FDA on March 4, and Vendetti sees gains in store as he believes clinical data supports its approval in October. In the ZOTRIP Phase 2/3 clinical study, the drug was able to provide pain relief in 81% of patients two hours after treatment. Additionally, he reminds investors to consider the implications of the therapy beyond migraines. “Furthermore, we believe the company's ADAM technology can be used as a drug delivery system for future immunotherapy, proteins, and biologics,” he explained.The analyst concluded, "The acceptance of the NDA for Qtrypta by the FDA represents another positive step towards bringing an innovative therapy for migraine sufferers to market, and we believe that the capital raises get ZSAN closer to the PDUFA goal date of October 20, 2020, a potentially transformative date for the company. We are bullish on the opportunity for its Adhesive Dermally Applied Microarray (ADAM) technology."As a result, Vendetti rates Zosano shares a "buy" alongside a $2.00 price target which implies nearly 260% upside from current levels. (To watch Vendetti’s track record, click here)Biocept Inc. (BIOC)Biocept is developing cutting-edge diagnostic solutions that can possibly provide critical information to both cancer patients and doctors using a simple blood test called liquid biopsy. Given the technology’s potential, some members of the Street see big things in store.This is the case for Mintz as his fund added a BIOC holding to the portfolio on March 2. Acquiring a 9.71% stake in the company, Sabby Capital spent $3.6 million to buy 9 million shares.Like Mintz, Maxim Group’s Jason McCarthy has high hopes for the biotech. He doesn’t dispute the fact that in liquid biopsy, the actual circulating tumor DNA (ctDNA) only represents a small percentage of circulating DNA and the rest gets released as a normal part of the cell’s life cycle in the form of cfDNA. That being said, he points out, “Biocept’s Switch-Blocker technology is designed to suppress amplification of wild-type targets, without suppressing mutant sequences containing even one single nucleotide variant (SNV). On top of this, the technology allows for real-time PCR.It doesn’t hurt that the “Clinical validation of qPCR Target Selector assays using highly specific switch-blockers for rare mutation detection” study supports the use of liquid biopsy and switch blocker technology. In the study, which looked at the EGFR, BRAF and KRAS gene mutations, a high concordance between Target Selector liquid biopsy and traditional biopsy was discovered.“Demonstrating concordance to tissue is an essential step in establishing a liquid biopsy. Tissue is the gold standard, though isn't always practical and can have issues relating to tumor heterogeneity. The new data helps further display the performance of Target Selector, which should help drive continued adoption in 2020,” McCarthy commented.It should also be noted that these mutations are seen in several types of cancers, and that two approved therapies, Tagrisso and Mekinist, targeting these mutations generated $3 billion and $1.3 billion, respectively, in 2019.To this end, McCarthy stayed with the bulls, reiterating his Buy rating and $1 price target. Should the target be met, a 186% twelve-month gain could be in the cards. (To watch McCarthy’s track record, click here)Heat Biologics (HTBX)With its proprietary T-cell Activation Platform (TCAP), Heat Biologics has been able to create therapies that enable a patient’s own immune system to defend itself against cancer cells. Its two platforms, ImPACT and ComPACT, were designed based on the heat shock protein, gp96. Among the biotech’s fans is the Sabby Capital manager. His fund added a new position comprised of 4.3 million shares at $0.35 per share. The total purchase value comes in at more than $1.5 million, with the fund now a 7.49% owner of the company. More recently, HTBX has made a splash after it announced that through its subsidiary, Zolovax, it is launching a coronavirus vaccine program. Using gp96, the biotech will design a vaccine that takes advantage of the protein’s immune activating capabilities. According to Jason McCarthy, who also covers this stock, the fact that gp96 is used in both oncology and infectious diseases makes it especially promising in the battle against coronavirus.In addition, McCarthy believes that the technology’s efficacy in other infectious diseases bodes well for the company. “Previously, the gp96 platform has been evaluated in numerous NIH (National Institutes of Health) and DOD (U.S. Department of Defense)-funded preclinical trials, against HIV/SIV, malaria, Zika and other infectious diseases. The results demonstrated potent immune response and induction of mucosal immunity in animal models,” the analyst noted.Even though HTBX has been weighed down thanks to exchange agreements around warrants, McCarthy points out that since February 28, shares are up 82%.Based on all of the above, McCarthy left both his Buy rating and $1 price target unchanged. This conveys his confidence in HTBX’s ability to soar 67% in the next twelve months.To find good ideas for biotech stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights.

Zosano Pharma Corporation (ZSAN)  (the “Company” or “Zosano”), a clinical-stage biopharmaceutical company, today announced the pricing of its previously announced underwritten public offering of (i) 10,146,154 Class A Units, each consisting of one share of common stock and one Series C Warrant to purchase one share of common stock, at a public offering price of $0.65 per Class A Unit, and (ii) 2,161,539 Class B Units, each consisting of one Series D Pre-Funded Warrant to purchase one share of common stock and one Series C Warrant to purchase one share of common stock, at a public offering price of $0.6499 per Class B Unit. The Company has granted the underwriter a 30-day option to purchase up to an additional 1,846,153 shares of common stock and/or additional Series C Warrants to purchase up to 1,846,153 shares of common stock.

After several tireless days we have finished crunching the numbers from nearly 750 13F filings issued by the elite hedge funds and other investment firms that we track at Insider Monkey, which disclosed those firms' equity portfolios as of September 30th. The results of that effort will be put on display in this article, as […]

A registration statement relating to these securities has been filed with the U.S. Securities and Exchange Commission (SEC) and became effective on March 27, 2019. The offering was made only by means of a written prospectus and prospectus supplement that forms a part of the registration statement. A final prospectus supplement and the accompanying prospectus relating to the offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov.

Zosano Pharma Corporation (ZSAN), a clinical-stage biopharmaceutical company, today announced the appointment of Christine Matthews as the company’s chief financial officer (CFO). Ms. Matthews, who previously served as interim CFO, will be responsible for leading the finance and accounting departments. “We are pleased to appoint Christine to the position of chief financial officer,” said Steven Lo, president and chief executive officer of Zosano.

Zosano Pharma Corporation (ZSAN), a clinical-stage biopharmaceutical company, today announced the submission of a 505(b)(2) New Drug Application (“NDA”) for Qtrypta™ to the U.S. Food and Drug Administration (“FDA”) for the acute treatment of migraine.

Zosano Pharma Corporation (ZSAN), a clinical-stage biopharmaceutical company, today announced that it has entered into a securities purchase agreement with several institutional investors providing for the issuance and sale of an aggregate of 2,181,034 shares of its common stock at a price of $1.45 per share in a registered direct offering. The securities described above are being offered pursuant to a shelf registration statement (File No. 333-229686), which was declared effective by the U.S. Securities and Exchange Commission (SEC) on March 27, 2019. When filed with the SEC, copies of the prospectus supplement and the accompanying base prospectus relating to this offering may be obtained at the SEC’s website at www.sec.gov.

Approaching the end of long drug-development journeys, these three Bay Area companies formally asked the FDA to approve potential treatments for hemophilia A, anemia in chronic kidney disease patients and migraines.

Just in time for Easter, the market delivered two consecutive sessions of gains. All three of the major U.S. stock indexes closed in the green on the last two days of the holiday-shortened trading week, rallying on the U.S. government’s additional interventions to mitigate COVID-19's economic impact. While the most recent surge was a welcome piece of good news, it came as somewhat of a surprise as the deadly virus continues to rampage parts of the U.S. and businesses remain shut down indefinitely. As a result, Wall Street pros argue that while we might not be out of the woods just yet, those ready to take on some risk have been presented with exciting opportunities. Specifically pointing to the biotech space, several compelling names are trading at low levels, making it affordable to snap up shares before a particular stock takes off. Seemingly at the drop of a hat, biotech companies can see their share prices soar on a single positive catalyst like favorable clinical data or regulatory approvals.With this in mind, we used TipRanks’ database to zero in on three biotech stocks trading for under $2 per share. After conducting our research, we found out that each is Buy-rated and boasts some serious upside potential.Trevena, Inc. (TRVN) Focused on developing therapies to improve the lives of patients with central nervous system (CNS) disorders, Trevena has an impressive development pipeline that could potentially help it do just that. While shares have fallen 37% year-to-date, putting the current share price at $0.51, some analysts believe its lead candidate, oliceridine, can drive massive upside. Oliceridine, an IV injection designed as an alternative to IV morphine for moderate to severe acute pain management, could be granted approval this summer, as the FDA recently accepted TRVN’s resubmission for review and set an August 7 PDUFA date. Based on a key opinion leader’s evaluation, JMP Securities analyst Jason Butler thinks there’s a strong likelihood the drug will ultimately be approved. While TRVN received a Complete Response Letter (CRL) in November 2018, new data from the QT trial addressed the safety concerns. Additionally, Dr. Timothy Beard, M.D., Chair of the Department of Surgery at Summit Medical Group, sees oliceridine as being an innovative drug. Butler wrote, “Dr. Beard stated that he is very familiar with the clinical data for oliceridine and believes the drug represents a truly novel advancement in pain management. He is impressed by the pain relief achieved with the drug and views the side effect profile as differentiated. He also commented that the data from the open-label extension trial is encouraging as it included a diverse range of patient populations.” On top of this, the candidate has demonstrated a clear role in higher-risk patients as well as the potential to improve patient experience and time to discharge in outpatient procedure centers. This is significant because performing procedures in an outpatient setting rather than in a hospital results in substantial savings for insurance companies. With three other candidates in development, it’s no wonder Butler is optimistic about TRVN. In line with this take, the four-star analyst maintained a Market Outperform rating and $4 price target. Should this target be met, shares could be in for a 684% twelve-month gain. (To watch Butler’s track record, click here) Looking at the consensus breakdown, it has been relatively quiet when it comes to other analyst activity. Only one other analyst has published a review recently, but it was also bullish, making the consensus rating a Moderate Buy. At $3.75, the average price target implies 635% upside potential. (See Trevena price targets and analyst ratings on TipRanks)Zosano Pharma Corporation (ZSAN) Another biotech targeting CNS conditions, Zosano has developed an intracutaneous microneedle patch system to deliver therapeutics and other bioactive molecules. At $0.60 apiece, the share price could represent the ideal time to acquire a position. Weighing in for H.C. Wainwright, analyst Raghuram Selvaraju commented, “In our view, Zosano looks like a sleeper that investors would be wise to assess carefully—the company's sole clinical-stage product candidate, Qtrypta, has completed pivotal development in acute migraine therapy with what we consider to be stellar results and is the subject of a potential October 20, 2020, U.S. approval decision.” The candidate is a formulation of an existing anti-migraine drug, zolmitriptan, in ZSAN’s patented microneedle array-containing, patch-based delivery device. According to pivotal data, the drug was able to produce fast onset pain relief, with 23% of patients experiencing results within 15 minutes and more than 80% of patients within two hours. Qtrypta achieved a strong result in terms of pain freedom and works well for patients with nausea who can’t swallow oral tablets and patients with a fear of visible needles, and thus, can’t use injectable triptans. Selvaraju added, “Only about 2% of patients in the Phase 3 trial reported triptan-like side effects (i.e., dizziness and paresthesia), indicating that Qtrypta may have a substantial safety and tolerability edge vs. other triptan-class drugs.” With Selvaraju expecting the company to target the roughly 5,000 specialist prescribers who routinely treat migraines and predicting it will be priced comparably to Eli Lilly’s drug, he estimates that Qtrypta could generate $30 million in sales during 2021 and peak sales of almost $300 million in 2026. Adding to the good news, COVID-19's effect on the company should be relatively limited as Qtrypta has already wrapped up pivotal testing and is under FDA review. To this end, Selvaraju kicked off his ZSAN coverage by issuing a Buy rating. Along with the bullish call, he set a $4 price target, suggesting shares could skyrocket 567% in the next year. (To watch Selvaraju’s track record, click here) Given that the biotech has received 2 Buy ratings compared to no Holds or Sells in the last three months, the word on the Street is that ZSAN is a Moderate Buy. Thanks to the $3 average price target, shares could potentially climb 400% higher in the next twelve months. (See Zosano price targets and analyst ratings on TipRanks)Moleculin Biotech, Inc. (MBRX) Last up, we have biotech company Moleculin, which has used its three core technologies to develop therapies for various forms of cancer. Unlike the other two names on our list, shares are up 143% in the last month, and at $1.14, its price tag still presents investors with an attractive entry point. The excitement surrounding MBRX is partly related to its potential treatment for COVID-19. The company announced that the University of Frankfurt’s research indicated 2-deoxy-D-glucose, “2-DG”, reduces COVID-19 replication by 100% in vitro. Even though this is promising, 2-DG metabolizes too quickly to be delivered to patients effectively, and thus, can only be used in vitro. That’s where MBRX comes in. It designed its candidate, WP1122, as a 2-DG pro-drug that could possibly address the metabolic challenges associated with 2-DG. Explaining the therapy’s implications, Maxim Group analyst Jason McCarthy stated, “WP1122 solves this problem with a modification to make a pro-drug which significantly increases the molecule's stability and permeability. Once WP1122 gets into a cell, the pro-drug acetyl groups are cleaved by esterases in the cytoplasm, and the active 2-DG molecule is released. This process induces 10X-plus uptake into tissues, something that standard 2-DG cannot achieve...WP1122 could change that for viral diseases, including COVID-19, as well as cancer indications.” Sure, additional clinical testing needs to take place, but McCarthy believes that early data is encouraging and he expects an IND filing for the candidate to come very soon. It should also be noted that MBRX has a research agreement with the University of Texas Medical Branch at Galvaston to study the efficacy of its compounds, including WP1112, in battling several viruses. Based on all of the above, McCarthy stayed with the bulls, reiterating a Buy recommendation and $3 price target. This implies shares could soar 165% in the next twelve months. (To watch McCarthy’s track record, click here) MBRX’s Moderate Buy consensus rating breaks down into only Buys, 2 to be exact. With a $2.50 average price target, the upside potential lands at 121%. (See Moleculin price targets and analyst ratings on TipRanks)

Zosano Pharma Corporation (ZSAN), a biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for Qtrypta™ for filing and substantive review. The Prescription Drug User Fee Act goal date for the completion of the FDA’s review of Qtrypta™ is set for October 20, 2020. This date reflects a standard 10-month review period and is consistent with the review timeline for a 505(b)(2) NDA submission.

FREMONT, Calif., March 13, 2020 -- Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, today announced financial results for the fourth quarter.

Q3 2019 Zosano Pharma Corp Earnings Call