The Daily Biotech Pulse: Novavax Vaccine Readout, Clinical Hold On Bellicum Study Lifted, Lilly Earnings, NLS Pharma IPO

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

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs Jan. 28)

• Abbott Laboratories ABT
• ABIOMED, Inc. ABMD (reacted to its third-quarter results)
• Amgen, Inc. AMGN (announced positive Phase 2 results for its lung cancer drug)
• Atea Pharmaceuticals Inc AVIR
• Collplant Biotechnologies Ltd – ADR CLGN
• Corcept Therapeutics Incorporated CORT
• Evelo Biosciences Inc EVLO
• Fulgent Genetics Inc FLGT
• Glaukos Corp GKOS
• Guardion Health Sciences Inc GHSI
• Illumina, Inc. ILMN
• Kaleido Biosciences Inc KLDO
• Krystal Biotech Inc KRYS
• Rubius Therapeutics Inc RUBY
• Vincerx Pharma Inc VINC
• ZIOPHARM Oncology Inc. ZIOP

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Jan. 28)

• Akouos Inc AKUS
• Avidity Biosciences Inc RNA
• Fusion Pharmaceuticals Inc FUSN
• Gracell Biotechnologies Inc GRCL
• Kinnate Biopharma Inc KNTE
• Virios Therapeutics LLC VIRI

Stocks In Focus

Novavax' Coronavirus Vaccine Shows High Efficacy In Late-stage U.K. Study

Announcing results from a Phase 3 study of its coronavirus vaccine candidate – NVX-CoV2373 – conducted in the U.K., Novavax, Inc. NVAX said the protein-based vaccine candidate met the primary endpoint, with a vaccine efficacy of 89.3%.

"NVX-CoV2373 is the first vaccine to demonstrate not only high clinical efficacy against COVID-19 but also significant clinical efficacy against both the rapidly emerging UK and South Africa variants," said Stanley Erck, CEO of Novavax.

In the South Africa Phase 2b clinical trial, 60% efficacy for the prevention of mild, moderate and severe COVID-19 disease was observed in the 94% of the study population that was HIV-negative, the company said.

Following delays, the company started late-stage study in the U.S. in late December.

The stock soared 26.48% to $169.50 in after-hours trading.

Vertex Gets Regulatory Nod to Commence Clinical Study of Diabetes Stem Cell Therapy

Vertex Pharmaceuticals Incorporated VRTX said the FDA cleared the investigational new drug application allowing it to begin a clinical trial for VX-880, an investigational stem cell-derived, pancreatic islet cell therapy to treat Type 1 diabetes.

Vertex said it plans to initiate a Phase 1/2 clinical trial in the first half of 2021 in patients who have T1D with impaired hypoglycemic awareness and severe hypoglycemia.

FDA Lifts Clinical Hold On Bellicum's Pancreatic/Prostate Cancer Study

Bellicum Pharmaceuticals Inc BLCM said the FDA has lifted the clinical hold on patient enrollment and dosing in an ongoing Phase 1/2 dose-escalation clinical trial evaluating BPX-601 and rimiducid in patients with previously treated metastatic pancreatic or prostate cancer.

The company said it can now resume enrollment without modification to the current study protocol.

The FDA had clamped a clinical hold on the trial in early December following the death of a pancreatic cancer patient in the trial reported to the agency by the company. The company and clinical investigators classified the patient death as unrelated to BPX-601 and rimiducid.

In after-hours trading, the stock jumped 65.89% to $6.37.

AIM ImmunoTech's Ampligen, Intranasal Formulation, To Be Tested In Phase 1 COVID-19 Study

AIM ImmunoTech Inc AIM said it has entered into a sponsorship agreement with Netherlands' Centre for Human Drug Research for the proposed Phase 1 clinical study on the safety of its drug Ampligen as an intranasal therapy, a critical step in the its ongoing efforts to develop Ampligen as a COVID-19 treatment.

In premarket trading Friday, the stock was adding 10.55% to $2.20.

Redhill Biopharma Given Nod to Proceed With Phase 2/3 COVID-19 Study Following Futility Analysis

RedHill Biopharma Ltd RDHL said the independent Data Safety Monitoring Board for the global Phase 2/3 study of opaganib in patients with severe COVID-19, unanimously recommended to continue the study following a pre-scheduled futility review of unblinded efficacy data from the first 135 patients treated in the study and safety data from the first 175 patients.

Offerings

Biondvax Pharmaceuticals Ltd – ADR BVXV said it will offer its ADSs in an underwritten public offering. The ADSs are being offered by the company, pursuant to an effective shelf registration statement on file with the SEC.

The stock was down 5.02% to $5.22 in after-hours trading.

Evelo Biosciences priced its underwritten public offering of 4.5 million shares of its common stock, at $15 per share. All of the shares in the offering are to be sold by the company.

Neuronetics Inc STIM priced its previously announced underwritten public offering of 4.84 million shares of its common stock, at $15.50 per share. The gross proceeds from this offering are expected to be approximately $75 million. The offering is expected to close on or about Feb. 2.

In after-hours trading, the stock was down 4.90% to $16.31.

Outlook Therapeutics Inc OTLK said due to demand, the underwriter has agreed to increase the size of the previously announced public offering and purchase on a firm commitment basis 35 million shares of common stock at a price to the public of $1 per share. The closing of the offering is expected to occur on or about Feb. 2.

The stock plunged 12.30% to $1.07 in after-hours trading.

Adamis Pharmaceuticals Corp ADMP said it intends to sell shares of its common stock in an underwritten public offering.

The stock retreated 10% to $1.26 in after-hours trading.

Cancer Genetics Inc CGIX said it has entered into securities purchase agreements with certain institutional and accredited investors to raise approximately $10 million.

The closing of the private placement is expected to occur on or about Feb.1.

In after-hours trading, the stock fell 15.21% to $4.07.

On The Radar

Earnings

Eli Lilly And Co LLY (Q4 Revenues climbed 22% year-over-year to $7.44 billion, and non-GAAP jumped 59% to $2.75; expects FY21 non-GAAP EPS at $7.75-$8.40 and revenue at $26.5 billion to $28.0 billion, in line with estimates)

IPOs

Switzerland-based NLS Pharmaceutics Ltd. priced its initial public offering of 4.8193 million units , at a price of $4.15 per unit. Each unit consists of one common share and one warrant to purchase one common share.

The common shares and warrants are immediately separable from the units and will be issued separately. The common shares and warrants have been approved for listing on the Nasdaq under the symbols NLSP and NLSPW. The company expects to raise gross proceeds of about $20 million from the offering. The warrants are exercisable immediately, expire five years from the date of issuance and will have an exercise price of $4.15 per share.

The offering is expected to close on Feb. 2, subject to customary closing conditions.

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