The Daily Biotech Pulse: Merck's Keytruda Snags Another FDA Approval, Pfizer Strikes COVID-19 Pill Supply Deal, Argenx Reports Positive Late-Stage Readout

Here's a roundup of top developments in the biotech space over the last 24 hours:

Stocks In Focus

Merck's Keytruda Monotherapy Approved For A Type Of Endometrial Cancer

Merck & Co., Inc. MRK said the U.S. Food and Drug Administration has approved its cancer immunotherapy as a single agent for the treatment of patients with advanced endometrial carcinoma that is microsatellite instability-high or mismatch repair deficient, as determined by a FDA-approved test.

These patients should have had disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.

Merck shares were up 0.18% to $79.20 in premarket trading.

Pfizer Announces Deal To Supply 4M Oral COVID-19 Treatments To Low- And Middle-Income Countries

Pfizer, Inc. PFE announced an agreement with UNICEF to supply up to 4 million treatment courses of its COVID-19 oral treatment Paxlovid to 95 low- and middle-income countries pending authorization or approval. These countries account for 50% of the world's population.

Financial details of the agreement were not disclosed. Pfizer expects supply to be available to support orders in April, and supply will continue throughout 2022, pending regulatory authorization or approval and according to country needs.

AnaptysBio CEO Quits, Board Member Named Takes Over On Interim Basis

AnaptysBio, Inc. ANAB announced the appointment of Daniel Faga as interim chief executive officer, effective immediately. Faga will take over from Hamza Suria, who has stepped down from his roles as president, CEO and board member.

The company also said its board will do a strategic portfolio review, under which it will define the clinical path forward across a breadth of potential inflammation-focused indications that could be pursued for each of its clinical and preclinical therapeutic antibody programs. It will also look into the optimal deployment of its approximately $615 million in cash as of the end 2021.

Novartis Announces Measures to Comply With Russian Sanctions

Novartis AG NVS said, to comply with international sanctions imposed upon Russia, it is implementing measures that include suspension of capital investments, media advertisements and promotion activities in the country.

It also paused the initiation of new trials and enrollment of new study participants in existing ones. Yet the company said it remains committed to provide access to medicines to patients in all countries in which it operates. The company also said it has made a $3-million donation to charities to support refugees and displaced people in Ukraine and bordering countries.

The stock was retreating 1.27% to $84.99 in premarket trading.

Orphazyme Initiates Delisting Of ADSs From Nasdaq

Orphazyme A/S ORPH, which has had trouble getting its investigational treatment arimoclomol past regulatory hurdles, said it has initiated the delisting of its ADSs and filed a Form 25 with the SEC. The delisting is expected to become effective on March 31.

The stock was slipping 10.04% to 76 cents in premarket trading.

Related Link: The Week Ahead In Biotech (March 20-26): Focus On Zogenix FDA Decision, Dermatology Conference Presentations & Earnings

Argenx Announces Positive Phase 3 Data For Rare Neuromuscular Disease Treatment

argenx SE ARGX announced positive topline data from the Phase 3 study evaluating subcutaneous efgartigimod for the treatment of generalized myasthenia gravis (gMG).

SC efgartigimod achieved the primary endpoint of total IgG reduction from baseline at day 29, demonstrating statistical noninferiority to Vyvgart intravenous formulation in gMG patients. Based on these results, argenx said it plans to submit a biologics license application BLA to the FDA by the end of 2022.

The stock was advancing 1.76% to $303.75 in premarket trading.

Oric Shelves Phase 1b Studies Of ORIC-101 In Solid Tumors, Prostate Cancer

Oric Pharmaceuticals, Inc. ORIC said following the planned interim analyses of two Phase 1b studies, it concluded that ORIC-101 did not demonstrate sufficient clinical activity to warrant further development. ORIC-101 was studied in combination with nab-paclitaxel in various solid tumors and in combination with enzalutamide in metastatic prostate cancer.

The company said it will now focus on advancing its three single agent programs – ORIC-533 in multiple myeloma, ORIC-114 in EGFR/HER2 cancers and ORIC-944 in prostate cancer.

The stock was retreating 2.84% to $6.49 in premarket trading.

Adamis To Voluntarily Recall Certain Lots Of Allergy Treatment Due to Potential Needle Clogging  

Adamis Pharmaceuticals Corporation ADMP said it is voluntarily recalling certain lots of Symjepi (epinephrine) Injection 0.15 mg and 0.3 mg pre-filled single-dose syringes to the consumer level. The batches were being recalled due to the potential clogging of the needle, preventing the dispensing of epinephrine.

US WorldMeds, which exclusively markets and distributes Symjepi in the U.S., will handle the entire recall process for Adamis, with Adamis oversight. Symjepi is manufactured and tested for Adamis by Catalent, Inc. CTLT Belgium S.A.

Adamis shares were moving down 5.29% to 60.56 in premarket trading.

Click here to access Benzinga's FDA calendar.

Offerings

Applied Genetic Technologies Corporation AGTC said it has commenced an underwritten public offering of its common stock. All of the shares in the proposed offering are being sold by the company.

In premarket trading, the stock was plunging 22.22% to $1.40.

Statera Biopharma, Inc. STAB said it has commenced an underwritten public offering. The units earmarked for the offering consist of one share of common stock and one warrant to purchase one share of common stock, and pre-funded units, consisting of one pre-funded warrant to purchase one share of common stock and one warrant to purchase one share of common stock.

The stock was slumping 27.71% to 46.53 cents in premarket trading.

On The Radar

Earnings

Aptose Biosciences Inc. APTO (after the close)
Caladrius Biosciences, Inc. CLBS (after the close)

Related Link: Attention Biotech Investors: Mark Your Calendar For March PDUFA Dates