The Daily Biotech Pulse: Moderna Gains On Vaccine News, Novartis Reports Q3 Beat, Adcom Reviews Authorization Of Pfizer-BioNTech's Vaccine For Children

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

Stocks In Focus

Anaptys Sells Royalties Due On Cancer Drug Jemperli To Sagard For $250M

AnaptysBio, Inc. ANAB announced the signing of an agreement with Sagard Healthcare Royalty Partners to monetize a portion of its future Jemperli royalties and milestones. AnaptysBio said it intends to utilize the proceeds of the transaction towards funding of its wholly owned preclinical and clinical-stage antibody programs.

Sagard will pay AnaptysBio $250 million upfront in exchange for royalties payable to AnaptysBio under its GlaxoSmithKline plc GSK collaboration on annual global net sales of Jemperli below $1 billion starting October 2021. The royalty rate applicable below the $1-billion annual net sales threshold is 8%.

Sagard may also receive up to a total of $105 million in potential cash milestones, of which $15 million are subject to certain future Jemperli regulatory filing and approval milestones and up to $90 million are subject to certain commercial sales milestones due prior to Jemperli achieving the $1 billion in annual global net sales threshold.

The stock was advancing 3.28% to $29.95 in premarket trading.

Moderna's Booster Dose Gets EMA Committee's Backing, Biopharma Strikes Deal To Supply 110M Doses To Africa

Moderna, Inc. MRNA said the European Medicines Agency's Committee for Medicinal Products for Human Use has concluded that a booster dose of Spikevax, Moderna's vaccine against COVID-19, at the 50 µg dose level may be considered in people aged 18 years and older at least six months after completion of the primary series.

Moderna's booster shot is already authorized in the U.S.

Separately, the company announced a new memorandum of understanding to make up to 110 million doses of the Moderna COVID-19 vaccine available to the African Union. The company said it is prepared to deliver the first 15 million doses in the fourth quarter of 2021, 35 million doses in the first quarter of 2022 and up to 60 million doses in second quarter 2022. All doses are offered at Moderna's lowest tiered price, in line with the company's global access commitments.

Moderna shares were gaining 0.83% to $352.45 in premarket trading.

Novartis Q3 EPS Beats Estimates

Novartis AG NVS's third-quarter revenues climbed 6% to $13 billion and core earnings per share climbed from $1.52 to $1.71. Analysts, on average, estimated EPS of $1.65 on sales of $13.3 billion.

For 2021, the company expects sales growth in the low- to mid-single digit range and core operating income to climb by mid-single digits. 

The stock was advancing 1.72% to $84.79.

Gilead, Merck Commence Midstage Study Of Combo HIV Treatment In Virologically Suppressed Adults

Gilead Sciences, Inc. GILD and Merck MRK announced the start of a Phase 2 clinical study evaluating an investigational once-weekly oral combination treatment regimen of islatravir and lenacapavir in people living with HIV who are virologically suppressed on antiretroviral therapy.

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

AstraZeneca Announces Positive Results From Late-Stage Biliary Duct Cancer Study

AstraZeneca plc AZN announced positive high-level results from the TOPAZ-1 Phase 3 trial, showing Imfinzi (durvalumab), in combination with standard-of-care chemotherapy, demonstrated a statistically significant and clinically meaningful overall survival benefit versus chemotherapy alone as a first-line treatment for patients with advanced biliary tract cancer.

The combination also demonstrated an improvement in progression-free survival (PFS) and overall response rate, key secondary endpoints.

4D Molecular Report Positive Phase 1/2 Data For Gene Therapies In Fabry Disease, Choroideremia

4D Molecular Therapeutics FDMT announced interim clinical data from the Phase 1/2 clinical trial of intravenous 4D-310 in patients with Fabry disease and a clinical data update from the ongoing Phase 1/2 clinical trial of 4D-110 in patients with choroideremia.

"These data support our belief that 4D-310 is well-tolerated, and has the potential to deliver patient benefit after a single intravenous injection. Importantly, the post-treatment AGA enzyme activity in patients' blood was within, or significantly above, the normal range despite the presence of pre-existing anti-AGA antibodies, which are a result of prior ERT in these patients," said David Kirn, CEO of 4DMT.

To date, at the 3E11 vg/eye dose, 4D-110 was well-tolerated with no dose-limiting toxicities or serious adverse events. Initial signals of clinical activity were observed at this dose, through anatomical measurements of the retinal pigment epithelium by fundus autofluorescence area and photoreceptors by ellipsoid zone area.

Aziyo, Medtronic To Terminate Distribution Agreement Related to Former's Cellular Bone Matrix Products

Aziyo Biologics, Inc. AZYO announced that it was informed by Medtronic plc MDT that, after conducting a thorough review of customer and patient needs, Medtronic has made the decision to cease distribution of cellular bone matrix products. As a result of this decision, the two companies are working toward a mutual termination of their FiberCel distribution agreement.

Aziyo also announced preliminary revenue of approximately $11.5 million for the three months ended Sept. 30, compared to $11.8 million for the year-ago period. The preliminary revenue estimate is in line with the $11.48-million Street estimate. 

SQZ Gets DSMB Nod For Advancing Investigational Vaccine Into Phase 1/2 Combo Study With Checkpoint Inhibitors

SQZ Biotechnologies SQZ announced that the independent Data and Safety Monitoring Board (DSMB) for the Phase 1/2 clinical trial SQZ-PBMC-HPV-101 has recommended that the trial advance into the combination stage with checkpoint inhibitors. The investigational cell-based vaccine is being evaluated in HLA-A*02+ patients with recurrent, locally advanced or metastatic HPV16+ solid tumors.

Click here to access Benzinga's FDA Calendar.

On The Radar

Adcom Calendar

FDA's Vaccines and Related Biological Products Advisory Committee will meet in an open session, scheduled between 8:30 a.m. and 5 p.m., to discuss a request to amend Pfizer, Inc. PFE-BioNTech SE BNTX's emergency use authorization for administration of their COVID-19 mRNA vaccine to children 5 through 11 years of age.

Clinical Readouts

Nanobiotix S.A. NBTX will present at the American Society of Radiation Oncology 2021 Annual Meeting, data from the Phase 1 Study of Novel Radioenhancer NBTXR3 in locally advanced HNSCC patients (at 2:15 pm).

9 Meters Biopharma, Inc. NMTR is scheduled to present at the American College of Gastroenterology 2021 Annual Scientific Meeting, Phase 2 data vurolenatide, its therapeutic candidate in short bowel syndrome.


Eli Lilly and Company LLY (before the market open)
Myovant Sciences Ltd. MYOV (before the market open)

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

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