Outlook Therapeutics Inc Faces 60.9% Drop After FDA Response on ONS-5010

Written by Emily J. Thompson, Senior Investment Analyst

BHVN-0.55%

CANG+4.58%

INBS-2.53%

Source: Benzinga

Updated: Jan 02 2026

0mins

Source: Benzinga

FDA Rejection: Outlook Therapeutics Inc's resubmission for the ONS-5010 biologics license application received a complete response letter from the FDA, indicating that the application cannot be approved in its current form, leading to a 60.9% drop in pre-market trading to $0.62, severely impacting investor confidence.
Severe Market Reaction: The significant decline in Outlook Therapeutics' stock price reflects market concerns over its future product development prospects, which may hinder financing efforts and delay research progress.
Other Stock Movements: In pre-market trading, Intelligent Bio Solutions Inc's stock fell 19.2% to $7.70 following the announcement of a $10 million private placement, indicating a decreased risk appetite among investors in the biotech sector.
Overall Market Trend: While Nasdaq 100 futures rose about 1%, several stocks showed weakness in pre-market trading, suggesting that investor sentiment in the biotech sector is shaken, which could affect overall market mood.

BHVN

$12.67+Infinity%1D

Analyst Views on BHVN

Wall Street analysts forecast BHVN stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for BHVN is 15.09 USD with a low forecast of 9.00 USD and a high forecast of 30.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.

14 Analyst Rating

8 Buy

6 Hold

0 Sell

Moderate Buy

Current: 12.740

Low

9.00

Averages

15.09

High

30.00

Current: 12.740

Low

9.00

Averages

15.09

High

30.00

RBC Capital

Sector Perform -> Outperform

upgrade

$9 -> $22

2026-01-21

Reason

RBC Capital

Price Target

$9 -> $22

AI Analysis

2026-01-21

upgrade

Sector Perform -> Outperform

Reason

RBC Capital upgraded Biohaven to Outperform from Sector Perform with a price target of $22, up from $9. The stock's reward/risk is "more compelling" following Biohaven's recent data, the analyst tells investors in a research note. The firm believes the data "take the worst-case scenario off the table and changes the risk profile of a key upcoming catalyst." In addition, Biohaven's degrader updates highlight the platform's potential in both Graves disease and IgA Nephropathy, contends RBC. The firm says the company's improved financial position and valuation discount relative to the platform's opportunity "creates a compelling setup" into the second half of 2026 catalysts.

Stifel

Paul Matteis

Buy

maintain

2025-12-26

Reason

Stifel

Paul Matteis

Price Target

2025-12-26

maintain

Buy

Reason

Stifel analyst Paul Matteis is reiterating a Buy rating on Xenon Pharmaceuticals (XENE) following Biohaven's (BHVN) Kv7 drug failing in a study in major depression disorder as the firm continues to believe that there's limited evidence suggesting that Biohaven's Kv7 compound BHV-7000 will be as efficacious as XEN1101. The firm, which continues to like Xenon shares heading into a pivotal 2026 with Phase 3 data for '1101 in FOS, keeps a Buy rating on Xenon shares.

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H.C. Wainwright

Neutral

maintain

$11

2025-12-26

Reason

H.C. Wainwright

Price Target

$11

2025-12-26

maintain

Neutral

Reason

H.C. Wainwright is not surprised by Biohaven's (BHVN) BHV-7000 study failure in major depressive disorder. However, investors have largely been focused on the company's readout in focal onset seizures, the analyst tells investors in a research note. H.C. Wainwright believes the depression failure reinforces its caution headed into the seizures readout. It adds that Biohaven's miss does not meaningfully influence its expectations for Xenon Pharmaceuticals' (XENE) azetukalner Phase 3 study in major depressive disorder. H.C. Wainwright keeps a Neutral rating on Biohaven with an $11 price target.

William Blair

Myles Minter

Market Perform

maintain

2025-12-26

Reason

William Blair

Myles Minter

Price Target

2025-12-26

maintain

Market Perform

Reason

William Blair analyst Myles Minter keeps a Market Perform rating on Biohaven after the company's Phase II study miss for BHV-7000 in major depression disorder. While disappointing, William Blair was cautious into the study given difficulties in depression clinical trial execution and placebo creep in trials over recent years, the analyst tells investors in a research note. The firm looks to the pivotal data for BHV-7000 in focal onset epilepsy in first half of 2026 as a key data point to determine if the extended-release formulation of the drug is an active formulation. It sees limited negative readthrough to Xenon Pharmaceuticals' (XENE) depression study from Biohaven's miss.

About BHVN

Biohaven Ltd. is a biopharmaceutical company focused on the discovery, development and commercialization of treatments in key therapeutic areas, including immunology, neuroscience, and oncology. It is advancing its portfolio of therapeutics, leveraging its drug development experience and multiple proprietary drug development platforms. Its clinical and preclinical programs include Kv7 ion channel modulation for epilepsy and mood disorders; extracellular protein degradation for immunological diseases; TRPM3 antagonism for migraine and neuropathic pain; TYK2/JAK1 inhibition for neuroinflammatory disorders; glutamate modulation for obsessive-compulsive disorder (OCD) and spinocerebellar ataxia (SCA); myostatin inhibition for neuromuscular and metabolic diseases, including spinal muscular atrophy (SMA) and obesity; antibody recruiting bispecific molecules; and antibody drug conjugates for cancer. Its advanced product candidate from its glutamate receptor antagonist platform is troriluzole.

About the author

Emily J. Thompson

Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.