The Daily Biotech Pulse: Moderna Awaits Adcom Ruling On COVID-19 Booster Shot; Teligent Files For Chapter 11; CFO Transitions at Catalyst Biosciences, CRISPR; Lucid Diagnostics Debuts

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

Stocks In Focus

Catalyst Biosciences Announces Resignation Of CFO

Catalyst Biosciences, Inc. CBIO announced that its chief financial officer, Clinton Musil, has resigned for personal reasons effective Oct. 29. Seline Miller, the company's controller, has been promoted to senior vice president, finance and will serve as interim chief financial and principal accounting officer while the company initiates a search for a successor.

Orthopediatrics Preannounces Below-Consensus Q3 Revenues

OrthoPediatrics Corp. KIDS announced preliminary third-quarter revenue of about $25.1 million, up 13% year-over-year but trailing the consensus estimate of $26.48 million. The company clarified that quarterly revenue was impacted by increased COVID-19 delta variant cases as well as respiratory syncytial virus cases within the children's hospitals combined with hospital staff shortages.

Despite this impact, the company said it is reiterating its 2021 total revenue guidance range of $97 million to $101 million, surrounding the $98.74-million consensus estimate.

Turning Point Announces Clinical Collaboration For Studying Combo Therapy In Lung Cancer Patients With Certain Mutations

Turning Point Therapeutics, Inc. TPTX announced a clinical collaboration to evaluate elzovantinib, its drug candidate targeting MET, SRC and CSF1R, in combination with aumolertinib, in patients with EGFR mutant MET-amplified advanced non-small cell lung cancer.

Aumolertinib is EQRx's drug candidate targeting EGFR.

Under the terms of the agreement, Turning Point will sponsor and conduct a Phase 1b/2 clinical trial to evaluate the safety, tolerability and preliminary efficacy of the combination regimen and will assume all costs associated with the trial. EQRx will provide aumolertinib at no cost. Turning Point is targeting initiation of the clinical trial in 2022, pending filing of an investigational new drug application with the Food and Drug Administration.

The stock was adding 2.06% to $48 in premarket trading.

CRISPR Announces Departure of CFO, Names Former Translate Bio Executive To The Post

CRISPR Therapeutics CRSP announced the appointment of Brendan Smith as chief financial officer effective Thursday. Smith brings more than 20 years of financial, operational and strategic leadership experience, including as CFO of Translate Bio, the company said. He succeeds Michael Tomsicek, who is retiring after four years at the company.

The stock was up 1.01% at $97.75 in premarket trading.

Related Link: The Week Ahead In Biotech (Oct. 10-16): Avadel FDA Decision, Conference Presentations And IPOs Take Center Stage

Teligent Files For Chapter 11 Bankruptcy Protection

Specialty generic pharma company Teligent, Inc. TLGT announced that it has, together with certain of its affiliates, filed for voluntary protection under Chapter 11 of the U.S. Bankruptcy Code in the U.S. Bankruptcy Court for the District of Delaware to pursue a sale process that is intended to maximize the value of the company.

The company began a marketing process ahead of the Chapter 11 filing to determine the level of market interest and is in ongoing discussions with several interested parties. It expects to consummate a sale of the entire business or its core assets by early 2022. Meanwhile, Teligent's Canadian affiliate, Teligent Canada, will be pursuing an out-of-court sale process.

The stock was retreating 37.12% to 20.95 cents in premarket trading.

Roche Announces European Regulatory Nod For Shorter Infusion Gazyvaro In Advanced Follicular Lymphoma Patients

Roche Holding AG RHHBY announced European Medicines Agency approval of a new, shorter 90-minute Gazyvaro infusion time, administered in combination with chemotherapy in patients with previously treated or untreated advanced follicular lymphoma.

Fortress Biotech Partner Company Announces Positive Results From Pivotal Studies of Menkes Disease Treatment

Fortress Biotech, Inc. FBIO partner company Cyprium Therapeutics and its licensing partner Sentynl Therapeutics announced positive results from an efficacy and safety analysis of data integrated from two completed pivotal studies in patients with Menkes disease treated with CUTX-101.

The stock was up 5.48% to $3.27 in premarket trading.

In both pre-specified primary and secondary efficacy analysis, treatment with CUTX-101 demonstrated a significantly greater median overall survival compared to untreated historical control patients.

These data will be presented as a virtual poster at the 2021 American Academy of Pediatrics National Conference & Exhibition.

Click here to access Benzinga's FDA Calendar.

On The Radar

Adcom Meetings

FDA's Vaccines and Related Biological Products Advisory Committee is meeting Thursday to discuss a booster dose of the Moderna, Inc. MRNA COVID-19 vaccine.


Medical device maker PAVmed Inc. PAVM's spin-off unit Lucid Diagnostics Inc. LUCD has priced its initial public offering of 5 million shares at $14 compared to the estimated price range of $14-$16. The New York-based company's shares will begin trading on the Nasdaq under the ticker symbol "LUCD."

Lucid is a commercial-stage medical diagnostics technology company focused on treating patients with gastroesophageal reflux disease, also known as chronic heartburn, acid reflux or simply reflux, who are at risk of developing esophageal precancer and cancer, specifically highly lethal esophageal adenocarcinoma.

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

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