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

Stocks In Focus

Novavax Shares React to Reports Of Manufacturing Issues With Its COVID-19 Vaccine

The company also announced data from the Phase 2 combo vaccination study carried out by Oxford University, using its vaccine as the second dose in a heterologous regimen. Separately, an SEC filing by the company showed Gregory Glenn, its President, R&D, sold 1,183 shares in the company at $170 per share.

The stock was slumping 18.16% to $131.40 in premarket trading.

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Molecular Partners to Present Positive Data For COVID-19 Treatment

Akero's NASH Drug Gets FDA's Fast Track Designation

Akero Therapeutics, Inc. (NASDAQ:AKRO) announced that the FDA has granted fast track designation to its lead program investigating efruxifermin for the treatment of non-alcoholic steatohepatitis.

The stock was advancing 3.54% to $22.21 in premarket trading.

Sesen Bio Gains On FDA Granting Request For Type A Meeting to Discuss Vicienum CRL

The stock was up 14.85% to $1.16 in premarket trading.

Merck Recalls a Lot of Antibiotic On Report of Contamination With Glass Piece

Merck & Co., Inc. (NYSE:MRK) said it is voluntarily recalling one lot of Cubicin(daptomycin for injection) 500 mg for intravenous use. The recall has been initiated following receipt of a customer complaint reporting that a piece of glass was found in a vial of Cubicin after reconstitution.

Approximately 22,000 vials are affected by this recall.

ObsEva Announces Positive Data For Linzagolix In Uterine Fibroids and Severe Adenomyosis

ObsEva SA (NASDAQ:OBSV) announced the presentation of clinical data from PRIMROSE Phase 3 study of linzagolix for the treatment of uterine fibroids as well as final data from a pilot study of linzagolix for the treatment of severe adenomyosis at the American Society for Reproductive Medicine 2021 Scientific Congress & Expo.

Once daily treatment of 200 mg linzagolix without add-back therapy, or ABT, reduced uterine volume by 39% after 24 weeks. However, co-administration of hormonal ABT after 24 weeks counteracted the uterine volume reducing effects at 52 weeks.

Additionally, a high dose of 200 mg linzagolix reduced uterine volume by 55% from baseline at 12 weeks and 32% from baseline at 24 weeks after continued treatment with 100 mg linzagolix. Pelvic pain was markedly reduced at 12 and 24 weeks with initial signs of reduction after 4 weeks. Overall, significant improvements in quality of life were reported.

The stock was adding 2.19% to $2.18 in premarket trading.

LumiraDx COVID-19 Antigen Test Authorized For Emergency Use In India

LumiraDx (NASDAQ:LMDX) announced it has received emergency use approval by India's Central Drugs Standard Control Organisation for its SARS-CoV-2 Antigen test for use in India. The test detects antigen nucleocapsid protein from a nasal swab with results in under 12 minutes from sample application.

The stock was skyrocketing 56.58% to $13.20 in premarket trading.

Satsuma, Precision Biosciences React to Fund Buying, Insider Buying

Commodore Capital said in a filing that it held 3.209 million shares of Satsuma Pharmaceuticals, Inc. (NASDAQ:STSA). The fund also bought 162,194 shares of the company.

The stock was up 9.16% to $5.60 in premarket trading.

Precision BioSciences, Inc. (NASDAQ:DTIL) revealed in a filing, CEO Michael Amoroso exercised stock options and bought 864,208 shares in the biopharma.

In premarket trading, the stock was adding 3.63% to $10.29.

Earnings

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

On The Radar

Clinical Readouts

28th Annual Congress of the European Society of Gene and Cell Therapy Presentations

Tenaya Therapeutics, Inc. (NASDAQ:TNYA): new preclinical data for TN-201, its AAV-based gene therapy product candidate for patients carrying mutations of the MYBPC3 gene.

Rocket Pharmaceuticals, Inc. (NASDAQ:RCKT): interim results from the Phase 1/2 study of lentiviral-mediated ex-vivo gene therapy for pediatric patients with severe leukocyte adhesion deficiency-I

Earnings

Abbott Laboratories (NYSE:ABT) (before the market open)
Biogen Inc. (NASDAQ:BIIB) (before the market open)

IPOs

Pennsylvania-based Context Therapeutics, Inc. priced its initial public offering of 5 million shares at $5 per share, for raising gross proceeds of $25 million. The company's shares will begin trading on the Nasdaq under the ticker symbol CNTX. Context is a clinical-stage biopharma developing therapies for women living with cancer.