The Daily Biotech Pulse: Larimar Plunges On Extension Of Clinical Hold, ImmunityBio Gains On Positive Data, Adcom Test Awaits Avenue Therapeutics

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

Stocks In Focus

ImmunityBio Says Cancer Combo Therapy Produces Positive Results In Late-Stage Bladder, Thyroid Cancer Studies

ImmunityBio, Inc. IBRX announced positive data from its late-stage bladder cancer trial of intravesical BCG plus Anktiva. The combo produced sustained complete response rates in patients with BCG-unresponsive non-muscle invasive carcinoma in situ bladder cancer and with papillary disease.

Of the 83 patients, 59, or about 71%, had a complete response with a median duration of response of 24.1 months — exceeding historical complete response rates of 41% and 18% for the FDA-approved therapies pembrolizumab and valrubicin, respectively.

In the papillary disease arm of the study (Cohort B), 57% of patients were disease free at 12 months and 53% at 18 months.

The stock was adding 10.09% to $6.33 in premarket trading.

Larimar Say FDA Maintained Its Earlier-Imposed Clinical Hold On CT1-1601 Study In Friedreich Ataxia Patients

Larimar Therapeutics, Inc. LRMR said the U.S. Food and Drug Administration has communicated its decision regarding maintaining the clinical hold on the CTI-1601 program.

CTI-1601 is a recombinant fusion protein intended to deliver human frataxin into the mitochondria of patients with Friedreich's ataxia who are unable to produce enough of this essential protein.

The regulatory has also sought additional data to resolve the clinical hold. Larimar said it is reassessing guidance on the timing of the planned Jive open-label extension and pediatric multiple-ascending dose clinical trials as it works to meet the agency's request.

The stock was plunging 57.59% to $3.55 in premarket trading.

Cerevel Announces Positive Phase 1 Data From Acute Anxiety Study

Cerevel Therapeutics Holdings, Inc. CERE announced positive results from its Phase 1 healthy volunteer clinical trial to evaluate darigabat in acute anxiety. Both the 7.5 mg twice-daily and the 25 mg twice-daily doses of darigabat demonstrated clinically meaningful and statistically significant improvement in the Panic Symptoms List score after eight days of dosing compared with placebo.

Related Link: The Week Ahead In Biotech (Feb. 13-19): Agios FDA Meeting, Avenue Adcom, Earnings And More

Zealand Pharma Completes Enrollment In Second Late-Stage Study Of Dasiglucagon For Treating Congenital Hyperinsulinism

Zealand Pharma A/S ZEAL announced completion of patient enrollment in the second Phase 3-trial of dasiglucagon for the treatment of congenital hyperinsulinism in neonates up to 12 months old. Top line results from the second Phase 3 trial are expected in the second quarter of 2022, and if the trial is positive, Zealand said it plans to file for marketing approval with the FDA based on data from both Phase 3 trials and an ongoing long-term extension safety trial.

The stock was adding 2.54% to $16.98 in premarket trading.

LianBio's Mavacamten Gets Breakthrough Designation From Chinese Regulator For Treating Heart Disease

LianBio LIAN announced that the Center for Drug Evaluation of the National Medical Products Administration granted breakthrough therapy designation in China for mavacamten for the treatment of patients with obstructive hypertrophic cardiomyopathy.

Click here to access Benzinga's FDA calendar.

Earnings

Aytu Biopharma, Inc. AYTU reported that its second-quarter revenues climbed 53% year-over-year to $23.1 million and the net loss per share narrowed from 72 cents to 44 cents. The company also said its PREVEnt pivotal study for AR101 in vascular Ehlers-Danols syndrome is on track to begin in mid-2022. It also plans to initiate sham-controlled study of healight in patients with SARS-CoV-2 shortly.
The stock was adding 8.87% to $1.35 in premarket trading.

On The Radar

Adcom Calendar

A joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee will discuss Avenue Therapeutics, Inc.'s ATXI new drug application for tramadol hydrochloride injection for the management of moderate to moderately severe pain in adults in a medically supervised health care setting.
The issues for the committees to discuss include the clinical relevance of tramadol hydrochloride injection, an opioid intended for management of acute pain in a medically supervised health care setting, when its onset of action is delayed, and its proposed dosing is a fixed-dosing regimen.

The shares were down 2.46% in premarket trading.

Earnings

Royalty Pharma plc RPRX (before the market open)
AtriCure, Inc. ATRC (after the market close)
Pacific Biosciences of California, Inc. PACB (after the market close)
Adaptive Biotechnologies Corporation ADPT (after the market close)
Corcept Therapeutics Incorporated CORT (after the market close)
Masimo Corporation MASI (after the market close)

Related Link: Attention Biotech Investors: Mark Your Calendar For These Key February PDUFA Dates