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Biotech Stock Roundup: CGEN Up on GILD Deal, MRNA Gains on Study Data & More
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It has been a busy week for the biotech sector, with a lot of updates on collaborations, study read-outs and other news. Shares of Compugen (CGEN - Free Report) soared following a deal with bigwig Gilead Sciences (GILD - Free Report) . Moderna (MRNA - Free Report) gained on study data.
Recap of the Week’s Most Important Stories:
Gilead Collaborates With Compugen: Gilead Sciences entered into an agreement with clinical-stage cancer immunotherapy company Compugen to license its pre-clinical immunotherapy program.
Per the terms of this license agreement, Compugen is responsible for the ongoing pre-clinical development and the future phase I study of immuno-oncology candidate COM503, following which Gilead will assume the rights to develop and commercialize COM503. The company will make an upfront payment of $60 million to Compugen. CGEN is also eligible for a milestone payment of $30 million subject to investigational new drug clearance of COM503, expected in 2024.
Compugen is entitled to an additional $758 million in future development, regulatory and commercial milestone payments, with a total deal value of $848 million, along with single-digit to low double-digit tiered royalties on worldwide net sales.
COM503 is a potential first-in-class, high-affinity antibody that blocks the interaction between IL-18 binding protein and IL-18, thereby releasing natural IL-18 in the tumor microenvironment and inhibiting cancer growth. The license agreement will reduce Gilead’s bottom line by approximately 3-5 cents.
Shares of Compugen surged 174% on the license news. The license agreement will reduce Gilead’s bottom line by approximately 3-5 cents.
bluebird Down on Capital: bluebird bio, Inc. (BLUE - Free Report) shares tanked after it announced the pricing of the underwritten public offering of 83.3 million shares of its common stock at an offer price of $1.50 per share. The company has also granted the underwriters a 30-day option to purchase up to an additional 12.5 million shares of its common stock at the public offer price after deducting underwriting discounts and commissions.
bluebird expects to generate $125 million (gross proceeds) from the offering. bluebird intends to use the net proceeds of the offering to support the commercialization and manufacturing of its three approved gene therapies — Zynteglo, Skysona and Lyfgenia. The capital will also be used to fund working capital and other general corporate purposes.
bluebird’s cash, cash equivalents, marketable securities and restricted cash balance totaled approximately $227 million as of Sep 30, 2023. The company anticipates full-year 2023 net cash burn to be in the range of $270-$300 million. bluebird was expected to raise capital as it needs funds to commercialize its three approved therapies.
Moderna Surges on Cancer Study Data: Moderna (MRNA - Free Report) shares gained after it announced follow-up data from the phase II KEYNOTE-942 on its individualized neoantigen therapy (INT) candidate mRNA-4157/V940 in patients with resected high-risk melanoma (stage III/IV) following complete resection. The study evaluated the combination mRNA-4157 and Merck’s blockbuster immuno-oncology drug Keytruda in this patient population.
At a median planned follow-up of approximately three years, treatment with mRNA-4157/Keytruda combination reduced the risk of recurrence or death by 49% compared with those treated with Keytruda alone. Treatment with this combination also reduced the risk of developing distant metastasis or death by 62% compared with Keytruda alone.
Both companies had earlier reported that the KEYNOTE-942 study achieved its primary endpoint of recurrence-free survival. The above results demonstrate the significant benefit of combining mRNA-4157 with Keytruda over a longer period compared with Keytruda alone. Moderna’s share price likely rose on this encouraging update.
ARGX Down on Study Failure: argenx SE (ARGX - Free Report) announced dismal top-line results from the ADDRESS study evaluating efgartigimod subcutaneous (SC) (efgartigimod alfa and hyaluronidase-qvfc) in adults with pemphigus vulgaris (PV) and pemphigus foliaceus (PF). The study results show the proportion of PV patients achieving the primary endpoint of complete remission on a minimal dose of steroids was not significantly different between efgartigimod SC and placebo. Shares tanked on the results.
Consequently, argenx will not pursue additional development in pemphigus and plans to prioritize clinical development of efgartigimod in its ongoing severe autoimmune indications. argenx is also reviewing the BALLAD study considering the ADDRESS results and the comparable biology between pemphigus and bullous pemphigoid. The company has decided not to make a decision at this time but rather wait for learnings from all currently enrolled patients and consider a new trial design for the path forward.
Performance
The Nasdaq Biotechnology Index has lost 2.18% in the past five trading sessions. Among the biotech giants, Moderna has gained 9.66% during the period. Over the past six months, shares of Moderna have plunged 30.62%. (See the last biotech stock roundup here: Biotech Stock Roundup: BLUE, CRSP & VRTX Get Gene Therapy Nod, ACAD Up on Patent News).
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What's Next in Biotech?
Stay tuned for more pipeline updates.
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Biotech Stock Roundup: CGEN Up on GILD Deal, MRNA Gains on Study Data & More
It has been a busy week for the biotech sector, with a lot of updates on collaborations, study read-outs and other news. Shares of Compugen (CGEN - Free Report) soared following a deal with bigwig Gilead Sciences (GILD - Free Report) . Moderna (MRNA - Free Report) gained on study data.
Recap of the Week’s Most Important Stories:
Gilead Collaborates With Compugen: Gilead Sciences entered into an agreement with clinical-stage cancer immunotherapy company Compugen to license its pre-clinical immunotherapy program.
Per the terms of this license agreement, Compugen is responsible for the ongoing pre-clinical development and the future phase I study of immuno-oncology candidate COM503, following which Gilead will assume the rights to develop and commercialize COM503. The company will make an upfront payment of $60 million to Compugen. CGEN is also eligible for a milestone payment of $30 million subject to investigational new drug clearance of COM503, expected in 2024.
Compugen is entitled to an additional $758 million in future development, regulatory and commercial milestone payments, with a total deal value of $848 million, along with single-digit to low double-digit tiered royalties on worldwide net sales.
COM503 is a potential first-in-class, high-affinity antibody that blocks the interaction between IL-18 binding protein and IL-18, thereby releasing natural IL-18 in the tumor microenvironment and inhibiting cancer growth. The license agreement will reduce Gilead’s bottom line by approximately 3-5 cents.
Shares of Compugen surged 174% on the license news. The license agreement will reduce Gilead’s bottom line by approximately 3-5 cents.
bluebird Down on Capital: bluebird bio, Inc. (BLUE - Free Report) shares tanked after it announced the pricing of the underwritten public offering of 83.3 million shares of its common stock at an offer price of $1.50 per share. The company has also granted the underwriters a 30-day option to purchase up to an additional 12.5 million shares of its common stock at the public offer price after deducting underwriting discounts and commissions.
bluebird expects to generate $125 million (gross proceeds) from the offering. bluebird intends to use the net proceeds of the offering to support the commercialization and manufacturing of its three approved gene therapies — Zynteglo, Skysona and Lyfgenia. The capital will also be used to fund working capital and other general corporate purposes.
bluebird’s cash, cash equivalents, marketable securities and restricted cash balance totaled approximately $227 million as of Sep 30, 2023. The company anticipates full-year 2023 net cash burn to be in the range of $270-$300 million. bluebird was expected to raise capital as it needs funds to commercialize its three approved therapies.
bluebird currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Moderna Surges on Cancer Study Data: Moderna (MRNA - Free Report) shares gained after it announced follow-up data from the phase II KEYNOTE-942 on its individualized neoantigen therapy (INT) candidate mRNA-4157/V940 in patients with resected high-risk melanoma (stage III/IV) following complete resection. The study evaluated the combination mRNA-4157 and Merck’s blockbuster immuno-oncology drug Keytruda in this patient population.
At a median planned follow-up of approximately three years, treatment with mRNA-4157/Keytruda combination reduced the risk of recurrence or death by 49% compared with those treated with Keytruda alone. Treatment with this combination also reduced the risk of developing distant metastasis or death by 62% compared with Keytruda alone.
Both companies had earlier reported that the KEYNOTE-942 study achieved its primary endpoint of recurrence-free survival. The above results demonstrate the significant benefit of combining mRNA-4157 with Keytruda over a longer period compared with Keytruda alone. Moderna’s share price likely rose on this encouraging update.
ARGX Down on Study Failure: argenx SE (ARGX - Free Report) announced dismal top-line results from the ADDRESS study evaluating efgartigimod subcutaneous (SC) (efgartigimod alfa and hyaluronidase-qvfc) in adults with pemphigus vulgaris (PV) and pemphigus foliaceus (PF). The study results show the proportion of PV patients achieving the primary endpoint of complete remission on a minimal dose of steroids was not significantly different between efgartigimod SC and placebo. Shares tanked on the results.
Consequently, argenx will not pursue additional development in pemphigus and plans to prioritize clinical development of efgartigimod in its ongoing severe autoimmune indications. argenx is also reviewing the BALLAD study considering the ADDRESS results and the comparable biology between pemphigus and bullous pemphigoid. The company has decided not to make a decision at this time but rather wait for learnings from all currently enrolled patients and consider a new trial design for the path forward.
Performance
The Nasdaq Biotechnology Index has lost 2.18% in the past five trading sessions. Among the biotech giants, Moderna has gained 9.66% during the period. Over the past six months, shares of Moderna have plunged 30.62%. (See the last biotech stock roundup here: Biotech Stock Roundup: BLUE, CRSP & VRTX Get Gene Therapy Nod, ACAD Up on Patent News).
Image Source: Zacks Investment Research
What's Next in Biotech?
Stay tuned for more pipeline updates.