The Daily Biotech Pulse: Calliditas Snags FDA Nod, Novartis to Buy Back $15B In Shares, Valneva Touts Vaccine Data, Immix, Bionomics Debut On Wall Street

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

Stocks In Focus

Calliditas Gets Conditional Approval For Kidney Inflammation Disease Drug

Calliditas Therapeutics AB (publ)'s CALT announced the U.S. Food and Drug Administration has approved Tarpeyo delayed release capsules to reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression.

This indication is approved under accelerated approval. It has not been established whether Tarpeyo slows kidney function decline in patients with IgAN. Continued approval may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.

The stock was surging 41.2% to $26.32 in premarket trading.

Mesoblast Says FDA Agrees On Additional Trial That Could Potentially Lead To Approval Of Stem Cell Therapy For Low Back Pain

Following the receipt of feedback from FDA's Office Of Tissues And Advanced Therapies, Mesoblast Ltd MESO said it plans to conduct an additional U.S. Phase 3 trial for its stem cell therapy rexlemestrocel-L in patients with chronic low back pain due to degenerative disc disease refractory to available therapies, including opioids. The additional trial may support submissions for potential approval in both the U.S. and EU.

Cumulative milestone payments could reach $1 billion depending on the final outcome of Phase 3 studies and patient adoption. Mesoblast will also receive tiered double-digit royalties on product sales.

The stock was adding 9.66% to $5.45 in premarket trading.

Biogen Announces Schedule For Aduhelm Post-Marketing Study

Biogen, Inc. BIIB and Eisai Co., Ltd. ESALY provided an update on the continuing progress of the Phase 4 post-marketing confirmatory study of Aduhelm.

The companies anticipate submitting the final protocol for review to the FDA in March 2022, with the initiation of patient screening in May 2022. The primary completion date is expected to be approximately four years after the study begins. The trial will also include a long-term extension to collect longer-term treatment data for up to 48 months.

Novartis To Buy Back $15B In Stock

Novartis AG NVS announced that it will initiate a share buyback of up to $15 billion to be executed by the end of 2023. The buyback is funded through the proceeds from the recent sale of 53.3 million Roche Holding AG RHHBY bearer shares.

The company is expected to commence the buyback in the coming days and to conclude by the end of 2023.

The stock was adding 3.75% to $84.58 in premarket trading.

Related Link: The Week Ahead In Biotech (Dec. 12-18): Hematology Conference Presentations, FDA Decisions For Calliditas, Argenx, Intra-Cellular & Eagle Pharma And More

Verrica Announces FDA Acceptance Of Resubmitted Application For Viral Skin Infection Treatment

Verrica Pharmaceuticals, Inc. VRCA announced that the FDA acknowledged that Verrica's resubmitted new drug application for VP-102 for the treatment of molluscum contagiosum was complete and assigned a PDUFA goal date of May 24, 2022.

The shares were rallying 11.47% to $10.50 in premarket trading.

SAB COVID-19 Treatment Candidate Found Effective Against Omicron Variant

SAB Biotherapeutics SABS announced data demonstrating that SAB-185, its therapeutic candidate for the treatment of COVID-19 infections, retains neutralization activity against the omicron SARS-CoV-2 variant in an in vitro pseudovirus model.
The data were generated by scientists at the FDA's Center for Biologics Evaluation and Research.

Novavax's Partner Takeda Files For Authorization Of COVID Vaccine In Japan

Novavax, Inc. NVAX announced the submission of a NDA to the Ministry of Health, Labour and Welfare in Japan for its COVID-19 vaccine by its partner Takeda Pharmaceutical Company Limited TAK.

Novavax shares were up 2.52% to $184.02 in premarket trading.

Valneva Announces Positive Booster Data From Phase 1/2 Study Of COVID-19 Vaccine Candidate

Valneva SE VALN announced positive homologous booster data from the Phase 1/2 study, of its inactivated, adjuvanted COVID-19 vaccine candidate, VLA2001. Initial results confirm that VLA2001 significantly boosted immunity in participants who received VLA2001 as a primary vaccination.

The stock was jumping 13.77% to $58 in premarket trading.

Assertio Buys Otrexup Drug-Device Combo From Antares For $44M

Assertio Holdings, Inc. ASRT said it has acquired Otrexup, a drug-device combination, single dose once weekly auto-injector, from Antares Pharma, Inc. ATRS in the company's first new product acquisition since 2015.
The acquisition was made in a partially seller-financed transaction for a total purchase price of $44 million, inclusive of working capital investments.

Insider Transactions

Silverback Therapeutics, Inc. SBTX disclosed in a filing that Jonathan Root, a director of the company's board, sold 2.17 million shares in the company.

The stock was moving down 5.78% to $6.20 in premarket trading.

Earnings

Enzo Biochem, Inc. ENZ reported fiscal-year 2022, first-quarter revenues of $26.5 million, up 7% from the previous quarter. On a GAAP basis, the company reversed to a loss of 5 cents from a profit of 1 cent per share.

The stock was up 9.2% at $3.80 in premarket trading.

Offerings

Syndax Pharmaceuticals, Inc. SNDX priced its underwritten public offering of 3.157 million shares of its common stock, and to certain investors pre-funded warrants to purchase 1.143 million shares of its common stock at an exercise price of $0.0001.

The public offering price of each share of common stock is $17.50 and the public offering price of each pre-funded warrant is $17.4999 per underlying share. The aggregate gross proceeds from this offering are expected to be approximately $75.3 million.

The stock was slipping 7.8% to $17.49 in premarket trading.

Click here to access Benzinga's FDA Calendar.

On The Radar

Clinical Readouts

Kymera Therapeutics, Inc. KYMR is hosting its R&D, wherein the company will present key multiple-ascending dose data from the Phase 1 trial of KT-474 and updates on IRAKIMiD (KT-413) and STAT3 (KT-333) programs

Cullinan Oncology, Inc. CGEM will provide a clinical update on CLN-081 during a webinar at 8 a.m. Cullinan is evaluating various doses of CLN-081 in a Phase 1/2a trial in patients with non-small cell lung cancer harboring exon 20 mutations whose disease has progressed on or after prior therapy. The company has out-licensed Greater China rights for the investigational compound to Zai Lab Limited ZLAB.

X4 Pharmaceuticals, Inc. XFOR will host a virtual seminar "Understanding Primary Immunodeficiencies" at 8:30 a.m. to discuss new clinical data on mavorixafor, X4's late-stage clinical candidate.

IPOs

Immix Biopharma, Inc. IMMX, a biopharmaceutical company working on tissue-specific therapeutics targeting oncology and immuno-dysregulated diseases, priced its initial public offering of 4.2 million shares at $5 per share, for gross proceeds of $21 million. commissions and offering expenses.

The shares of common stock are expected to begin trading on the Nasdaq under the ticker symbol "IMMX."

Bionomics Limited, a clinical-stage biopharma, priced its U.S. IPO of 1.622 million ADSs, each representing 180 ordinary shares, at $12.35 per ADS, for raising gross proceeds of $20 million. The ADSs will begin trading on the Nasdaq under the symbol "BNOX."

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

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