The company also released headline unaudited results, showing lower revenues and a wider loss for fiscal year 2020.

The stock was up 3.41% to $2.12 in premarket trading Thursday.

Vertex Announces Australian Regulatory Nod For Triple Combo Cystic Fibrosis Therapy

Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) said the Australian Therapeutic Goods Administration has approved the use of Trikafta for people with cystic fibrosis, ages 12 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator gene, the most common CF-causing mutation worldwide.

Related Link: FDA Decisions For Pfizer, Eli Lilly And Bluebird Bio, Bristol-Meyers Squibb, Plus New Data And Earnings

Bristol-Myers Squibb Opdivo-Antibody Combo Therapy Aces Phase 2/3 Skin Cancer Study

Bristol-Myers Squibb (NYSE: BMY) announced positive primary results from the Phase 2/3 trial evaluating the fixed-dose combination of relatlimab, an anti-LAG-3 antibody, and Opdivo versus Opdivo alone in patients with previously untreated metastatic or unresectable melanoma.

The company said the trial met its primary endpoint of progression-free survival. Follow-up for overall survival, a secondary endpoint, is ongoing. Additionally, the fixed-dose combination was well-tolerated and there were no new safety signals reported in either the relatlimab and Opdivo combination arm or the Opdivo arm.

G1's Recently Approved Cosela Included In 2 Updated Cancer Treatment Guidelines

G1 Therapeutics, Inc. (NASDAQ: GTHX) said its Cosela has been added to two updated National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology: the Treatment Guidelines for Small Cell Lung Cancer and the Supportive Care Guidelines for Hematopoietic Growth Factors.

View more earnings on IBB

It recently won the FDA nod for mitigating the effects of chemotherapy in lung cancer patients.

The stock was up 1.76% at $20.80 in premarket trading Thursday.

Synlogic Says Hyperoxaluria Treatment Achieves Proof of Mechanism In Phase 1 Study

Synlogic, Inc. (NASDAQ: SYBX) announced that SYNB8802 has achieved proof of mechanism in a dietary hyperoxaluria Phase 1 Part A study in which healthy volunteers on a high oxalate and low calcium diet were treated with multiple ascending doses of SYNB8802.

In the study's efficacy analysis, the percent change from baseline urinary oxalate levels were negative 28.6% compared to placebo, at the 3e11 live cell dose. This dose was well tolerated and will be used in Part B of the study, the company said.

The stock was down 6.96% premarket at $3.61.

Radius, Sio-Gene Gain On Insider Transactions

Radius Health, Inc. (NASDAQ: RDUS) said in a filing its chief business officer Chhaya Shah exercised options to buy shares.

Sio Gene Therapies, Inc. (NASDAQ: SIOX) revealed in a filing its CEO Pawan Cheruvu bought 100,000 shares in the company at $2.4814.

In after-hours trading, Radius stock was up 19.49% to $27.50, while Sio Gene gained 8.97% to $2.55.

Earnings

TELA Bio, Inc.'s (NASDAQ: TELA) fourth-quarter revenue climbed 17% year-over-year to $5.7 million in 2020, and the loss per share narrowed from $1.22 to 54 cents.

The stock climbed 14.29% to $16 in after-hours trading.

Offerings

Evofem Biosciences, Inc. (NASDAQ: EVFM) priced its underwritten public offering of 17.143 million shares of its common stock at a price to $1.75 per share. The gross proceeds from the offering to Evofem are expected to be approximately $30 million. The offering is expected to close on or about March 29. All of the shares of common stock in the offering are to be sold by Evofem.

In after-hours trading, the stock fell 10.73% to $2.08.

On The Radar Adcom Meeting

The FDA's Arthritis Advisory Committee, along with the Drug Safety and Risk Management Advisory Committee will likely announce its recommendation on Pfizer Inc.'s (NYSE: PFE) biologic license application for tanezumab subcutaneous injection for the proposed indication of relief of signs and symptoms of moderate to severe osteoarthritis in adult patients for whom use of other analgesics is ineffective or not appropriate. Tanezumab is being jointly developed by Pfizer and Eli Lilly and Company (NYSE: LLY).

Earnings

• Vascular Biogenics Ltd. (NASDAQ: VBLT) (before the market open)

• Genetron Holdings Limited (NASDAQ: GTH) (before the market open)

• Synlogic (before the market open)

• NovaBay Pharmaceuticals, Inc. (NYSE: NBY) (after the close)

• Neoleukin Therapeutics, Inc. (NASDAQ: NLTX) (after the close)

• OpGen, Inc. (NASDAQ: OPGN) (after the close)

• Eyenovia, Inc. (NASDAQ: EYEN) (after the close)

• HTG Molecular Diagnostics, Inc. (NASDAQ: HTGM) (after the close)

• CymaBay Therapeutics, Inc. (NASDAQ: CBAY) (after the close)

• BIOLASE, Inc. (NASDAQ: BIOL) (after the close)

• ADMA Biologics, Inc. (NASDAQ: ADMA) (after the close)

• Athersys, Inc. (NASDAQ: ATHX) (after the close)

• Processa Pharmaceuticals, Inc. (NASDAQ: PCSA)

• Panbela Therapeutics Inc. (NASDAQ: PBLA)

IPOs

Dutch biotechnology Lava Therapeutics B.V., which is developing bispecific antibodies engineered to selectively induce gamma-delta T cell-mediated immunity against tumor cells, priced its 6.7-million share initial public offering at $15, the midpoint of the estimated price range of $14-$16. The company's shares will begin trading on the Nasdaq under the ticker symbol LVTX.

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

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