AFMD News

Heidelberg, Germany, March 17, 2020 – Affimed N.V. (AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced the appointment of Dr. Arndt Schottelius as Chief Scientific Officer, effective April 2020. Dr. Schottelius will lead Affimed’s discovery, translational innovation and platform engineering teams.

Q3 2019 Affimed NV Earnings Call

Affimed N.V. (AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced that the first patient was successfully dosed in a Phase 1/2a clinical trial of AFM24, a first in human study evaluating AFM24 as monotherapy in patients with advanced solid malignancies whose disease has progressed after treatment with previous anticancer therapies. AFM24, a tetravalent, bispecific epidermal growth factor receptor (EGFR)- and CD16A-binding innate cell engager, is novel due to its activation of innate immunity to kill solid tumors, inducing both antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), as compared to other therapies that rely heavily on signal or checkpoint inhibition.

Here's a roundup of top developments in the biotech space over the last 24 hours.On a day when the three major averages shed over 4% in reaction to bleak forecasts concerning the COVID-19 pandemic's impact, none of the Nasdaq- or NYSE-listed biotech stocks hit 52-week highs or lows.Stocks In Focus InVitae Withdraws FY20 Guidance Due To Pandemic, Plans Offering InVitae Corp (NYSE: NVTA), a medical genetics company, pre-announced first-quarter results and said it expects revenue of more than $63 million, up 55% year-over-year, billable tests of 147,000, up 65%, and non-GAAP cash burn of less than $100 million. Analysts expect revenue of $60.3 million.Citing the unknown duration and extent of COVID-19's impact on its business and the health care system in general, the company said it is withdrawing its guidance for 2020.Separately, the company announced an underwritten public offering of 17.78 million shares priced at $9 per share. All the shares are being sold by the company. The company expects the offering to close April 6 and to raise gross proceeds of about $16 million.The stock was down 11.96% at $10.31 in Thursday's premarket session. Benzinga is covering every angle of how the coronavirus affects the financial world. For daily updates, sign up for our coronavirus newsletter.Novartis Terminates Agreement To Sell Sandoz US Assets To Aurobindo Novartis AG (NYSE: NVS) said it has mutually agreed with Aurobindo Pharma to terminate a previously announced deal to sell the Sandoz U.S. generic oral solids and dermatology businesses to Aurobindo. The decision follows a lack of FTC approval for the transaction within anticipated timelines.Novartis shares were adding 1.57% to $82.20 in premarket trading Thursday.Nevro Forecasts Q1 Revenue Shortfall, Withdraws 2020 Guidance Nevro Corp (NYSE: NVRO) announced preliminary unaudited worldwide revenue for the first quarter of $86.4 million to $86.9 million, up from $82.1 million a year ago. This compares to the $94.96-million consensus estimate. The company attributed the potential shortfall to a rapid deceleration in March due to COVID-19 shelter-in-place policies and restrictions on elective surgical procedures.The company also withdrew its 2020 guidance issued in late February due to the rapidly evolving environment and continued uncertainties related to COVID-19.Separately, the company announced a public offering of 1.625 million shares of common stock and $165 million in aggregate principal amount of convertible senior notes due 2025.The stock fell 3.86% to $86 in after-hours trading.OpGen Closes On Curetis Purchase OpGen Inc (NASDAQ: OPGN) announced the consummation of its proposed acquisition of Dutch molecular diagnostics company Curetis N.V. OpGen shares paid as consideration for the sale will be distributed to Curetis, which will be dissolved and delisted from the Euronext exchange.OpGen shares were trading 5.44% higher at $2.52 in Thursday's premarket session. See also: The Week Ahead In Biotech: Clinical Readouts, COVID-19 News Flow In Focus Amid Continuing Uncertainty Eiger's HDV Study To Be Delayed, Company To Support Studies Of Peginterferon Lambda In COVID-19 Issuing an update on clinical development activity and business operations, Eiger Biopharmaceuticals Inc (NASDAQ: EIGR) said it has taken appropriate steps to ensure the safety of patients and integrity of the HDV Phase 3 D-LIVR trial. The trial is evaluating lonafarnib and ritonavir with or without PEGylated interferon-alfa-2a in patients with chronic hepatitis D virus infection.It now expects the COVID-19 pandemic to lead to the shifting of the completion of enrollment in the study to 2021.The company also said it has begun supporting multiple investigator-sponsored studies of peginterferon lambda in COVID-19."These studies will assess a 180 mcg, once-weekly, subcutaneous dose of Lambda, and will enroll at academic centers across the U.S., as well as international sites," the company said.The shares advanced 6.27% to $6.27 in after-hours trading.Affimed's Lead Drug Gets Orphan Drug Designation In T-Cell Lymphoma Affimed NV (NASDAQ: AFMD) said the FDA has granted orphan drug designation to AFM13, its lead CD30- and CD16A-binding innate cell engager, for the treatment of patients with T-cell lymphoma.Affimed shares were up 6.92% to $1.70 in the premarket session. BioCryst Names Anthony Doyle As CFO BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX) announced the appointment of Anthony Doyle as CFO. Doyle previously served as a global contract research organization's CFO.In premarket trading Thursday, BioCryst shares were adding 0.26% to $1.90.Boston Scientific Lowers Q1 Revenue Guidance Due To COVID-19 Impact Boston Scientific Corporation (NYSE: BSX) lowered its first-quarter revenue growth guidance to flat to slightly up from its previous estimate for 10-12% growth. The company attributed the predicament to a significant decline in procedural volumes in March due to COVID-19 impact.Humanigen's Lenzilumab Gets FDA Nod For Compassionate Use In COVID-19 Patients Humanigen Inc (OTC: HGEN) said the FDA approved the administration of its lenzilumab for COVID-19 patients under individual patient emergency IND applications to patients under its compassionate use program.The company said it is advancing plans to conduct a multi-center, Phase 3 study of lenzilumab for the prevention of acute respiratory distress syndrome, ARDS and/or death in hospitalized patients with pneumonia associated with coronavirus 2 infection.Applied Therapeutics Opens IND With FDA For AT-001 To Treat COVID-19-Related Lung Inflammation, Cardiomyopathy Applied Therapeutics Inc (NASDAQ: APLT) said it has opened an INDA with the FDA for AT-001 to treat acute lung inflammation and cardiomyopathy in critical COVID-19 patients. The company noted that multiple AT-001 investigator-initiated trials are now underway to address these two issues.Vir, Alnylam Expand Existing Collaboration To Include Additional Targets In COVID-19 Treatment Vir Biotechnology Inc (NASDAQ: VIR) and Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY) announced an expansion of their existing collaboration for RNAi therapeutics for infectious diseases. The expansion includes up to three additional targets focused on host factors for SARS-CoV-2, including ACE2 and TMPRSS2, both of which are considered critical for viral entry.Vir shares were gaining 2.45% to $30.50 in premarket trading Thursday.Related Link: Attention Biotech Investors: Mark Your Calendar For These April PDUFA Dates See more from Benzinga * 10 Biotech Winners And Losers In Q1 * The Daily Biotech Pulse: InflaRx Begins Human Testing For COVID-induced Pneumonia, Chembio, Becton Dickinson Launch Coronavirus Tests(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

NEW YORK, NY / ACCESSWIRE / March 24, 2020 / Solebury Trout, a boutique investor relations and corporate communications firm, announced today that it will be hosting a Virtual Conference Series on March ...

Heidelberg, Germany, December 17, 2019 – Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company committed to giving patients back their innate ability to fight.

Heidelberg, Germany, April 1, 2020 – Affimed N.V. (AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to AFM13, its lead CD30- and CD16A-binding innate cell engager, for the treatment of patients with T-cell lymphoma. The granted designation includes peripheral T cell lymphoma (pTCL), a subtype of T-cell lymphoma.

Affimed N.V. (AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced that Dr. Florian Fischer, Chief Financial Officer (CFO) of Affimed, passed away this weekend due to complications related to neoplasia. Florian was a great partner and brought passion, leadership, commitment, as well as strong financial acumen to our company for 15 years.

Affimed N.V. (AFMD) might move higher on growing optimism about its earnings prospects, which is reflected by its upgrade to a Zacks Rank 2 (Buy).

Today is shaping up negative for Affimed N.V. (NASDAQ:AFMD) shareholders, with the analysts delivering a substantial...

This morning, Affimed issued a press release, which is posted on our website at www.affimed.com. On the call today with prepared remarks are Adi Hoess, Chief Executive Officer of Affimed; Andreas Harstrick, Chief Medical Officer; and Michael Wolf, Head of Finance.

Full Year 2019 Affimed NV Earnings Call

Heidelberg, Germany, April 2, 2020 – Affimed N.V. (AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today provided an update on its operations in response to the continued spread of the COVID-19 coronavirus pandemic. Affimed also announced that it will host a conference call on Tuesday, April 28, 2020 at 8:30 a.m. ET to discuss its full year 2019 financial results and recent corporate developments. “Our priority at this time is to ensure the safety and health of our employees, their families, our partners and the patients we serve, while also maintaining continuity of our business and ongoing clinical trials,” said Dr. Adi Hoess, Affimed’s CEO.

Heidelberg, Germany, February 19, 2020 – Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight.

Heidelberg, Germany, March 26, 2020 – Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight.

At the end of February we announced the arrival of the first US recession since 2009 and we predicted that the market will decline by at least 20% in (Recession is Imminent: We Need A Travel Ban NOW). In these volatile markets we scrutinize hedge fund filings…

Dr. Harstrick, formerly Chief Medical Officer at Molecular Partners and Senior Vice President Medical Sciences and Product Lead for Erbitux® at ImClone Systems/Eli Lilly, will.

AFMD earnings call for the period ending December 31, 2019.

Last week, you might have seen that Affimed N.V. (NASDAQ:AFMD) released its yearly result to the market. The early...

Shares of Affimed (NASDAQ:AFMD) rose 0.9% in pre-market trading after the company reported Q4 results.Quarterly Results Earnings per share decreased 223.53% year over year to ($0.21), which missed the estimate of ($0.19).Revenue of $4,331,000 lower by 83.30% year over year, which beat the estimate of $2,940,000.Outlook Earnings guidance hasn't been issued by the company for now.Revenue guidance hasn't been issued by the company for now.Details Of The Call Date: Apr 28, 2020View more earnings on AFMDTime: 02:05 PM ETWebcast URL: https://edge.media-server.com/mmc/p/e7owvfovRecent Stock Performance 52-week high: $3.7452-week low: $1.42Price action over last quarter: down 1.32%Company Description Affimed NV is a clinical-stage biopharmaceutical company. It is engaged in discovering and developing targeted cancer immunotherapies. Its product candidates are being developed in the field of immuno-oncology, which represents an approach to cancer treatment that seeks to harness the body's own immune defenses to fight tumor cells. It is also developing single and combination therapies to treat cancers and other life-threatening diseases. The company's operations are located in Germany, Europe, and the USA.See more from Benzinga * Recap: Provident Financial Q3 Earnings * 16 Consumer Cyclical Stocks Moving In Tuesday's Pre-Market Session * 16 Energy Stocks Moving In Tuesday's Pre-Market Session(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

Affimed researchers served as co-authors on an abstract for RO7297089 with scientific collaborators from Genentech, a member of the Roche GroupAffimed will host a live.

AFM24: First patient dosed in first-in-human clinical study for advanced EGFR-expressing solid tumors, including colon, lung and other cancersAFM13: Initiated.