Shares of Vertex Pharmaceuticals Incorporated VRTX were down 11.4% yesterday after the company announced data from a phase II study that evaluated its investigational, oral, highly selective NaV1.8 pain signal inhibitor, suzetrigine, for treating people with painful lumbosacral radiculopathy (“LSR”), a form of peripheral neuropathic pain.

Data from the study showed that treatment with suzetrigine led to a statistically significant and clinically meaningful within-group reduction in pain from baseline with a mean change in numeric pain rating scale of -2.02 at week 12, thereby meeting the primary endpoint.

However, the placebo arm demonstrated a similar reduction of -1.98 points, indicating not much difference between the two groups.

Shares of VRTX were down as investors were not too impressed with the data as it does not clearly demonstrate suzetrigine’s benefit-risk profile.

Year to date, shares of Vertex have lost 2.5% compared with the industry’s decline of 13.7%.

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More on VRTX's Study on Suzetrigine

The company also conducted post-hoc analyses to further evaluate the above efficacy results, which showed that there was variability in the placebo response across study sites.

Per the company, in around 40% of sites that had lower responses in the placebo arm, the suzetrigine arm within-group reduction in pain was similar to the overall study and had greater separation from the placebo arm.

Despite the lack of evidence that treatment with suzetrigine separates from treatment with placebo, VRTX plans to take suzetrigine into pivotal phase III development for painful LSR, pending discussions with regulatory bodies.

Based on the learnings from the phase II study and post-hoc analyses, the company will inform the phase III study design.

VRTX's Suzetrigine Nearing Potential FDA Nod in Acute Pain

Besides LSR, suzetrigine is also being developed for the treatment of acute pain and diabetic peripheral neuropathy.

The FDA accepted Vertex’s new drug application (“NDA”), seeking approval for suzetrigine in moderate-to-severe acute pain in July 2024. The regulatory body has granted a priority review to the NDA, with a decision expected on Jan. 30, 2025.

Earlier this year, Vertex initiated a pivotal phase III program of suzetrigine in diabetic peripheral neuropathy. This study is currently ongoing.

Per Vertex, suzetrigine has the potential to transform the treatment paradigm of pain, both acute and neuropathic. Suzetrigine is a non-opioid treatment option for pain, an area with limited treatment options, mostly highly addictive opioid-based medications.

However, the disappointing data from the LSR study raises doubt about the drug’s commercial potential for the acute pain indication, if approved.

VRTX's Zacks Rank & Key Picks

Vertex currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the biotech sector are Castle Biosciences, Inc. CSTL, CytomX Therapeutics, Inc. CTMX and Spero Therapeutics, Inc. SPRO, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for Castle Biosciences’ 2024 bottom line have moved from a loss of 59 cents to earnings of 34 cents. Loss per share estimates for 2025 have narrowed from $2.15 to $1.84 during the same time. Year to date, shares of CSTL have surged 25.5%.

CSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.

In the past 60 days, estimates for CytomX Therapeutics’ 2024 loss per share have narrowed from 29 cents to 5 cents. Loss per share estimates for 2025 have narrowed from 56 cents to 35 cents during the same time. Year to date, shares of CTMX have declined 29%.

CTMX’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 115.70%.

In the past 60 days, estimates for Spero Therapeutics’ 2024 loss per share have narrowed from $1.59 to $1.29. During the same time, estimates for 2025 loss per share have narrowed from $1.54 to 79 cents. Year to date, shares of SPRO have lost 32.3%.

SPRO’s earnings beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average surprise of 94.42%.

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