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Pharma Stock Roundup: FDA Nod to PFE Booster for Age 12-15, Breakthrough Tag to ABBV Drug

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This week, the FDA granted emergency approval to Pfizer’s (PFE - Free Report) booster dose for children 12-15 years of age and granted Breakthrough Therapy Designation (“BTD”) to AbbVie’s (ABBV - Free Report) lung cancer candidate. Eli Lilly (LLY - Free Report) announced a small collaboration deal. J&J (JNJ - Free Report) agreed to a $63 million settlement with Nevada resolving their opioid-related claims.

Recap of the Week’s Most Important Stories

FDA Approves Pfizer’s COVID Jab Booster for 12 to 15-Year Olds: The FDA extended the Emergency Use Authorization (EUA) for the booster dose of Pfizer/BioNTech’s COVID-19 vaccine to allow its use in adolescents 12 through 15 years of age.

Along with the approval for 12 to 15-year-olds, the FDA also amended the existing EUA to reduce the time between completion of primary series and booster dose for all eligible individuals who have taken a Pfizer vaccine to five months from six months previously set. The FDA also authorized a third primary series dose for children 5 through 11 years of age who are immunocompromised.

Pfizer and BioNTech’s booster dose was granted emergency approval by the FDA in November 2021 for all adults 18 years of age and older, following the completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine. In December, the EUA was extended to allow its use in individuals 16 and 17 years of age.

Meanwhile, the Centers for Disease and Control Prevention’s (CDC) recommended Pfizer/BioNTech’s booster shots for all individuals above 12 years of age, five months after their initial Pfizer/BioNTech vaccination series.

Pfizer and BioNTech signed a new collaboration to develop an mRNA-based vaccine for the prevention of shingles after witnessing success with their COVID-19 vaccine. Clinical studies on the mRNA-based shingles vaccine are expected to begin in the second half of 2022. The companies will make the vaccine by leveraging Pfizer’s antigen technology and BioNTech's proprietary mRNA platform technology, which has been used to make their successful COVID-19 vaccine.

For the deal, Pfizer will make an upfront payment of $225 million to BioNTech that will include an upfront cash payment of $75 million and an equity investment of $150 million. This is Pfizer and BioNTech’s third mRNA vaccine collaboration.

FDA’s Breakthrough Tag for AbbVie’s Novel Lung Cancer Candidate: The FDA granted BTD to AbbVie’s investigational antibody-drug conjugate (ADC) telisotuzumab vedotin (Teliso-V) for previously treated EGFR wild type non-small cell lung (NSCLC) cancer in patients with high levels of c-Met overexpression. Teliso-V is being studied in a phase II LUMINOSITY study in patients with second- or third-line NSCLC with c-Met overexpression while a phase III study is expected to begin in the first half of 2022.

J&J’s Nevada Opioid Settlement Agreement: J&J announced a $63 million settlement agreement with the State of Nevada in connection with its opioid-related lawsuits. The settlement is consistent with the terms of a previous nationwide opioid settlement agreement by J&J to pay about $5 billion over a period of nine years to settle all opioid lawsuits in both federal and state courts in the United States. J&J faces thousands of lawsuits related to the abuse of its opioid-based drugs including Duragesic, Nucynta and Nucynta ER. These lawsuits claim that J&J is one of the several companies whose opioid-based drugs were responsible for fueling the state’s opioid epidemic.

J&J announced data from a real-world study, which showed that its single-shot COVID-19 vaccine protects against breakthrough infections and hospitalizations for up to six months. J&J observed a modest waning of protection against breakthrough infection from the fourth month onward of the study period. For mRNA vaccines, protection against breakthrough infections waned at a higher rate for each month of follow-up.

Lilly’s New Deal for Neurological Therapies: Lilly in-licensed rights to Entos Pharmaceuticals' Fusogenix nucleic acid delivery technology to research and develop innovative therapies in multiple neurologic indications. The companies will develop proteo-lipid vehicles (PLV) for the delivery of Lilly’s therapeutic cargo to targets in the central and peripheral nervous systems. While Entos will take care of the generation, development and optimization of PLVs, Lilly will select PLVs for clinical development and commercialization. For the deal, Lilly will make an upfront payment of $50 million to Entos including an equity investment. Entos will also be entitled to receive up to $400 million in potential developmental and commercial milestone payments.

The NYSE ARCA Pharmaceutical Index declined 2.9% in the last five trading sessions.

Large Cap Pharmaceuticals Industry 5YR % Return

Large Cap Pharmaceuticals Industry 5YR % Return

Large Cap Pharmaceuticals Industry 5YR % Return

Here’s how the eight major stocks performed in the last five trading sessions.

Zacks Investment ResearchImage Source: Zacks Investment Research

In the last five trading sessions, Merck rose the most (2.2%) while Lilly declined the most (6.4%).

In the past six months, Pfizer recorded the maximum gain (42.2%) while Novartis declined the most (4.4%)

(See the last pharma stock roundup here: FDA Approves PFE & MRK’s Oral Pills for COVID & Other Drugs)

What's Next in the Pharma World?

Watch out for regular pipeline and regulatory updates next week.

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