The Daily Biotech Pulse: Entasis, Dermata Spike Higher On Positive Readouts, J&J Q3 EPS Beats Estimates, Wave Life Sciences Regains Right To CNS Portfolio

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

Stocks In Focus

Entasis Announces Positive Data For Late-Stage Study Of SUL-DUR In Acinetobacter Infections

Entasis Therapeutics Holdings, Inc. ETTX announced positive topline results from its ATTACK Phase 3 registrational trial evaluating the safety and efficacy of SUL-DUR versus colistin in patients with infections caused by Acinetobacter baumannii.

SUL-DUR, the company said, met the primary endpoint of 28-day all-cause mortality in patients with carbapenem-resistant Acinetobacter, demonstrating statistical non-inferiority versus colistin. Mortality analyses favored SUL-DUR versus colistin in CRABC m-MITT and all study populations included in the topline results.

At Test of Cure, there was a statistically significant difference in clinical response favoring SUL-DUR over colistin. SUL-DUR met the primary safety objective of the study achieving statistically significant reduction in nephrotoxicity.

The stock was up 21.22% to $3.77 in after-hours trading.

Wave Life Sciences Discontinues Central Nervous System Drug Collaboration With Takeda

Wave Life Sciences Ltd. WVE announced an amendment to its ongoing collaboration with Takeda Pharmaceutical Company Limited TAK that immediately discontinues the discovery research component of the collaboration that provided Takeda with the right to license multiple preclinical programs for central nervous system indications over a four-year research term.

Under terms of the amendment, Takeda will pay Wave $22.5 million for collaboration-related research and preclinical expenses. The amendment allows Wave to advance CNS programs independently or enter partnerships in the CNS field outside of the three specified targets, which are part of the ongoing late-stage collaboration between the companies.

Wave Life Sciences shares were adding 7.99% to $5 in premarket trading.

Pfizer-BioNTech Submits Application To Canadian Regulator For Authorization Of COVID-19 Vaccine In Children

Pfizer, Inc. PFE-BioNTech SE BNTX have submitted to Health Canada an application seeking authorization for the use of the Comirnaty COVID-19 vaccine in children 5 to 11 years of age.

This is the first submission Health Canada has received for the use of a COVID-19 vaccine in this younger age group.

A similar application is also under review in the U.S.

Pfizer shares were up 0.48% at $41.52 in premarket trading, while BioNTech was adding 2.34% to $267.20.

Dermata's DMT310 Aces Early Stage Psoriasis Study

Dermata Therapeutics, Inc. DRNA announced positive topline results from its Phase 1b trial of DMT310 in 30 patients as a once-weekly topical application for the treatment of mild-to-moderate psoriasis.

DMT310, Dermata's lead product candidate, has both mechanical and chemical mechanisms of action and is being investigated to treat multiple inflammatory skin conditions, including acne, psoriasis and rosacea.

In premarket trading, the stock was up 11.59% at $4.91.

Related Link: The Week Ahead In Biotech (Oct. 18-23): J&J, Biogen Kickstart Big Pharma Earnings, Regeneron-Sanofi, Roche Await FDA Decisions And IPOs

Celcuity Announces Clinical Trial Collaboration For Breast Cancer Study

Celcuity, Inc. CELC announced a clinical trial collaboration with the University of Rochester Wilmot Cancer Center and Puma Biotechnology PBYI to conduct a Phase 2 clinical trial of the latter's Nerlynx plus Roche Holding AG RHHBY's Xeloda in patients selected by the CELsignia Test who have metastatic HER2-negative breast cancer with brain metastases.

CELsignia is Celcuity's companion diagnostic platform, which can analyze live patient tumor cells to identify new groups of cancer patients likely to benefit from already approved targeted therapies.

Novartis's Zolgensma To Get Public Reimbursement In Quebec

Novartis AG NVS said the government of Quebec has decided to provide public reimbursement for
Zolgensma gene therapy for the treatment of children with spinal muscular atrophy.

The announcement takes effect Oct. 20.

Dr. Reddy's Gets FDA Nod For Generic Version Of Bristol-Myers Squibb's Revlimid

Dr. Reddy's Laboratories Ltd. RDY announced Food and Drug Administration's final approval of its abbreviated new drug application for lenalidomide capsules, in 2.5 mg and 20 mg strengths, and tentative approval for 5 mg, 10 mg, 15 mg and 25 mg strengths, a therapeutic equivalent generic version of Bristol-Myers Squibb Company BMY's Revlimid.

With this approval, Dr. Reddy's is eligible for 180 days of generic drug exclusivity for lenalidomide Capsules, 2.5 mg and 20 mg.

Calithera Acquires Two Oncology Assets For $45M

Calithera Biosciences, Inc. CALA announced an agreement with Takeda to acquire the latter's two clinical-stage compounds, both of which have demonstrated single-agent clinical activity with potential in biomarker-defined cancer-patient populations.
The compounds, sapanisertib and mivavotinib, further strengthen Calithera's pipeline of clinical-stage targeted therapies.

Calithera will pay Takeda $10 million in cash upfront and $35 million in its Series A preferred stock.

Additionally, Takeda will be eligible to receive from Calithera potential milestone payments and tiered royalties of high single-digits to low teens on future net sales.


Click here to access Benzinga's FDA Calendar.

On The Radar


Johnson & Johnson JNJ reported third-quarter net sales of $23.34 million, up 10.7% year-over-year, and adjusted EPS of $2.60, up 18.2%. This compared to the consensus estimate of $23.72 million in sales and $2.35 in adjusted EPS. The company raised its adjusted EPS guidance for the full year.

Intuitive Surgical, Inc. ISRG (after the close)

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

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